1. BACKGROUND. Lovastatin β-hydroxyacid No effect on methane production Inhibits cholesterol synthesis

Size: px
Start display at page:

Download "1. BACKGROUND. Lovastatin β-hydroxyacid No effect on methane production Inhibits cholesterol synthesis"

Transcription

1 1. BACKGRUND Methane production by the archeon Methanobrevibacter smithii (M. smithii) is a ubiquitous process in the intestine, disposing of hydrogen and other by-products formed during carbohydrate digestion by bacteria¹ Clinical and preclinical evidence have demonstrated that elevated intestinal methane production reduces gut motility and is an underlying cause of symptoms in irritable bowel syndrome with constipation (IBS-C)² Methane production by M. smithii in stool from IBS-C patients is inhibited by lovastatin lactone, but not by its β-hydroxyacid metabolite or other statins³ Stomach acid; Esterases Lovastatin lactone Inhibits methane production No effect on cholesterol synthesis Lovastatin β-hydroxyacid No effect on methane production Inhibits cholesterol synthesis ¹Gottlieb K et al. (2015) Aliment Pharmacol Ther 43: ²Triantafyllou K et al. (2014) J Neurogastroenterol Motil 20: ³Marsh E et al. (2015) Am J Gastroenterol 110 (Suppl 1): S753

2 2. BJECTIVES SYN-010 is a proprietary, modified-release formulation of lovastatin lactone, designed to reduce intestinal methane production and alleviate IBS-C symptoms without causing gross disruption of the microbiome (Figure 1) SYN-010 exerts its antimethanogenic effect in the intestine, so systemic absorption of lovastatin species from the SYN-010 formulation is not required In previous Phase 2a clinical trials, daily oral doses of SYN mg and 42 mg alleviated symptoms in a significant number of IBS-C patients¹, ² Increased bowel movement frequency, reduced abdominal pain score, improved bloating score, no drug-related diarrhea The current study evaluated the plasma pharmacokinetics and stool drug levels of lovastatin lactone and β-hydroxyacid in healthy volunteers administered daily oral doses of SYN mg, 42 mg and 84 mg Investigate the proposed drug release profile of the SYN-010 formulation Explore systemic exposure to lovastatin species after SYN-010 administration Determine whether methane-inhibiting levels of lovastatin lactone are delivered to the intestine by the SYN-010 formulation Advise whether additional SYN-010 doses should be tested in IBS-C clinical trials ¹Gottlieb K et al. (2015) Gastroenterol 150: S-496 ²Wacher V et al. (2016) Am J Gastroenterol 111 (Suppl 1): S256-7

3 SYN-010 Modified Release Lovastatin Lactone Figure 1: SYN-010 comprises a capsule containing combinations of lovastatin lactone tablets coated with different enteric polymers to prevent drug release in the stomach then deliver different lovastatin lactone doses to the duodenum (DR; blue tablet) and the ileocecal junction/colon (ICR) SYN mg Stomach Duodenum Jejunum Ileum Cecum Colon p p p p p p C 4 2 C 4 Bacterial overgrowth M. smithii overgrowth Bacteria M. smithii Bacteria M. smithii Capsule dissolves and enteric coatings prevent hydrolysis of lovastatin lactone¹ Duodenal release (DR) tablet disintegrates to release active lovastatin lactone in the duodenum Ileocecal release (ICR) tablets disintegrate to release active lovastatin lactone into the ileocecal junction and colon Reduce methane without killing microbes ¹Gastric absorption accounts for up to 30% of an immediate-release lovastatin dose; avoiding the stomach and preserving lovastatin in the lactone form is expected to lower systemic levels of the cholesterol-lowering β-hydroxyacid metabolite

4 3. CLINICAL STUDY DESIGN Fasted, healthy volunteers were randomly assigned to receive single oral doses of SYN mg, 42 mg or 84 mg each day for 4 days (Table 1)¹ Plasma samples were collected from all participants on day 1 (0-24 h) and day 4 (0-32 h) and stool samples were collected on each dosing day Plasma and stool samples were analyzed for lovastatin lactone and β-hydroxyacid using an LC-MS/MS method Potential systemic effects of SYN-010 were evaluated by measuring serum lipid parameters and markers of liver and muscle function Table 1: SYN-010 capsule configurations; ratio is DR:ICR tablets SYN mg SYN mg SYN mg + 1:2 1:5 2:10 ¹Doses were administered each morning after an overnight fast of at least 10 h and food was not restored until at least 2 h after the SYN-010 dose

5 4. RESULTS SYN-010 was well-tolerated at all doses and the few reported adverse events were all of mild intensity (Table 2) No serious adverse events were reported and no diarrhea was observed SYN-010 plasma pharmacokinetic profiles were consistent with negligible drug release in the stomach, followed by dual pulse release of different drug doses in the duodenum and the ileocecal region/colon (Figures 2, 3) Lovastatin β-hydroxyacid C max and AUC 0-24 for a single dose of SYN mg were ~50% of the values reported for single 40 mg doses of commercial lovastatin formulations (Mevacor, Altoprev )¹ in fasted healthy volunteers Lovastatin lactone stool levels on day 4 of SYN-010 dosing were equivalent to concentrations that inhibited methane production by 60% (21 mg) and 90% (42, 84 mg) in stool samples from IBS-C patients in vitro (Figures 4, 5) Stool concentrations of lovastatin lactone were >> β-hydroxyacid, consistent with limited presystemic conversion of lactone to β-hydroxyacid SYN mg and 42 mg doses did not cause meaningful changes to serum lipid parameters; however, reductions in cholesterol and triglycerides were observed with SYN mg (Table 3, Figure 6) ¹A head to head comparison was not conducted in this study; data for Mevacor and Altoprev are from

6 SYN-010 Pharmacokinetic Study Population Table 2: Baseline demographics and adverse event profile for subjects in the pharmacokinetic study Parameter SYN mg SYN mg SYN mg Baseline Demographics¹ No. Subjects (Female %) 8 (50%) 8 (50%) 8 (87.5%) White / Black, African American, % 87.5% / 12.5% 100% / % / 37.5% Age, years 51.1± ± ±15.3 Body weight, kg 81.2± ± ±16.1 BMI, kg/m² 28.9± ± ±3.0 Dose, mg/kg 0.26± ± ±107 Study drug compliance 100% 100% 100% Treatment Emergent Adverse Events² Withdrew, n Reported SAE, n Reported TEAE, n Description of TEAE (relationship to treatment)³ 01 Somnolence (probable) 02 eadache (probable) 03 Flatulence (probable) 04 eadache (possible) 05 Dyspepsia (probable) ¹Data are mean±sd unless indicated ²SAE = serious adverse event, TEAE = treatment emergent adverse event; numbers are masked Subject ID

7 SYN-010 Plasma Pharmacokinetics Day 1 Figure 2: Plasma levels of lovastatin lactone and β-hydroxyacid after one dose of SYN-010 (day 1) Lactone β-ydroxyacid 3 h delay until first visible plasma concentrations indicates negligible drug release in the stomach Continually increasing plasma levels over 24 h are consistent with drug release well into the colon Lovastatin β-hydroxyacid C max and AUC for the 42 mg dose are ~50% of the values reported for 40 mg doses of commercial lovastatin formulations evaluated in fasted healthy volunteers² Dose (n) C max (ng/ml)¹ AUC 0-24 (ng.h/ml)¹ Lactone -Acid Lactone -Acid SYN mg (8) 1.7± ±0.7 21±19 12±6 SYN mg (8) 2.7± ±1.6 35±41 19±20 SYN mg (8) 6.0± ±1.8 79±55 33±16 Mevacor 40 mg² 2.8± ±1.8 38±18 44±17 Altoprev 40 mg² 3.4± ±1.9 54±20 58±20 ¹Data are mean±sd (n=8); PK parameters calculated using noncompartmental methods ²A head to head comparison was not conducted in this study; data for Mevacor and Altoprev are from

8 SYN-010 Plasma Pharmacokinetics Day 4 Figure 3: Plasma lovastatin lactone and β-hydroxyacid levels after 4 doses of SYN-010 (day 4) Lactone β-ydroxyacid Steady state plasma levels appear to have been reached after 4 days of dosing The proposed dual pulse lovastatin lactone release profile is evident in the plasma concentration vs time profiles Lovastatin β-hydroxyacid plasma levels largely track with lactone levels, suggesting conversion of lactone to the β-hydroxyacid is predominantly systemic (post-absorption) Dose (n) C max (ng/ml)¹ AUC 0-32 (ng.h/ml)² Lactone -Acid Lactone -Acid SYN mg (8) 2.6± ±0.6 41±42 34±13 SYN mg (8) 3.6± ±4.1 76±41 63±76 SYN mg (8) 8.3± ± ± ±98 ¹Data are mean±sd; PK parameters calculated using noncompartmental methods. ²Area under the concentration vs time curve from 0-32 h (AUC 0-32 ) calculated using he linear trapezoidal method

9 SYN-010 Stool Concentrations Days 2-4 Figure 4: Stool levels of lovastatin lactone and β-hydroxyacid in samples collected on days 2-4 Lactone β-ydroxyacid (1/10 the scale of lactone) Antimethanogenic lovastatin lactone is the predominant lovastatin species in stool Day 4 lovastatin lactone stool levels were not significantly higher for SYN mg compared to SYN mg Lovastatin β-hydroxyacid stool levels were the same for the 21 mg and 42 mg doses, suggesting that stool β- hydroxyacid levels are largely determined by the DR component of the formulation Dose Lactone / β-hydroxyacid (n)¹ Day 2 Day 3 Day 4 SYN mg 14±13 (7) 28±38 (6) 10±12 (6) SYN mg 72±69 (5) 27±43 (7) 28±24 (7) SYN mg 40±49 (6) 18±24 (8) 13±17 (6) ¹Data are mean±sd *P<0.05 vs 21 mg, P<0.1 vs 21 mg, P<0.1 vs 42 mg (unpaired t-test)

10 Lovastatin Lactone Inhibits Methane Production in Stool Figure 5: Comparison of lovastatin lactone concentrations measured in the stool of healthy volunteers in vivo with lovastatin lactone concentrations used to inhibit methane production by stool samples from IBS-C patients in vitro¹ 5A: Lovastatin lactone ( mg/g stool wet weight) was incubated for 270 min in homogenates made from stool samples provided by high breath C 4 IBS-C patients¹. C 4 was measured in the reactor headspace using gas chromatography. To account for baseline variability, data are presented as change from time 0 ΔC 4 = C 4 at time (n) C 4 at time 0. 5B: A plot of ΔC 4 AUC (expressed as % of control) vs the inverse of lovastatin lactone stool concentration shows that lovastatin lactone concentrations in the stool of healthy volunteers were equivalent to concentrations that inhibited C 4 production in stool from IBS-C patients ΔC 4 AUC = area under the ΔC 4 concentration vs time curve from min (figure 5A) ¹Marsh E et al. (2015) Am J Gastroenterol 110 (Suppl 1): S753

11 Serum Chemistry Parameters Parameter (Units, normal range) ALT (U/L, 8-54) GGT (U/L, 5-85) Table 3: Serum chemistry parameters for subjects in the pharmacokinetic study Creatine Kinase (U/L, ) Cholesterol (mmol/l, ) DL-C (mmol/l, ) LDL-C (mmol/l, ) Triglycerides (mmol/l, ) Day SYN mg SYN mg SYN mg Δ 1 5 Δ 1 5 Δ 1 5 Δ 1 5 Δ 1 5 Δ 25 (15-39) 24 (14-40) 23.0 (11-40) 22.5 (10-34) (66-168) 56.5 (53-72)* 46.6% 5.22 ( ) 5.15 ( )* 5.2% 1.55 ( ) 1.30 ( )* 11.4% 3.08 ( ) 3.19 ( ) 1.44 ( ) 1.41 ( ) 18 (11-29) 18 (13-26) 23.5 (11-43) 20.5 (9-29)* 18.5% (75-221) 61.0 (40-81)* 47.6% 4.67 ( ) 4.34 ( )* 5.5% 1.26 ( ) 1.13 ( ) 3.06 ( ) 2.73 ( )* 7.3% 1.20 ( ) 1.29 ( ) 18 (9-36) 22 (10-37) 19.5 (9-26) 15.5 (8-20)* 14.5% 93.5 (52-204) 55.0 (41-129)* 34.5% 4.80 ( ) 3.92 ( )* 17.1% 1.22 ( ) 1.18 ( )* 10.7% 2.64 ( ) 2.19 ( ) 15.0% 1.07 ( ) 0.88 ( )* 25.3% ¹Data are median (range). Δ=Mean percentage change from Day 1 to Day 5. *P<0.05, P<0.1 vs Day 1 (paired t-test)

12 Changes in Cholesterol and LDL-C vs SYN-010 Dose Figure 6: Trend to alteration of serum lipid parameters at the SYN mg dose

13 5. CNCLUSINS Previous Phase 2a clinical trials showed that daily oral doses of SYN mg and 42 mg were well-tolerated and provided symptom improvements in a significant number of IBS-C patients¹, ² The present study found that SYN mg, 42 mg and 84 mg doses were well-tolerated in healthy volunteers over a 4-day dosing period and affirmed the proposed dual pulse lovastatin lactone release profile The present study also demonstrated that the SYN mg and 42 mg doses used in Phase 2a clinical trials are appropriate doses for continued clinical evaluation in larger Phase 2b/3 studies Stool concentrations suggest that SYN-010 doses less than 21 mg may not deliver effective methane-inhibiting lovastatin lactone levels to the intestine, while doses higher than 42 mg are not needed for inhibition of methane production Plasma pharmacokinetics and serum chemistry suggest that SYN-010 doses higher than 42 mg may deliver systemic levels of lovastatin species that could cause unnecessary alterations to liver and lipid parameters A Phase 2b/3 adaptive clinical trial design evaluating SYN mg and 42 mg doses in IBS-C patients for 12 weeks has been discussed with the FDA ¹Gottlieb K et al. (2015) Gastroenterol 150: S-496 ²Wacher V et al. (2016) Am J Gastroenterol 111 (Suppl 1): S256-7

14 JDDW CNFLICT-F-INTEREST DISCLSURE Authors: Vince Wacher; John Kokai-Kun; livia Coughlin; Candy Lionetti; Klaus Gottlieb; Joseph Sliman Affiliation: Synthetic Biologics, Inc., Rockville, MD, USA (all authors) CI Related to this Presentation: 1 Advisor: 2 Stock wnership/profits: 3 Royalties: 4 Lecture Fees: 5 Manuscript Fees: 6 Consigned/Joint Research Expenses: 7 Scholarship Donations: 8 Course Affiliations: VW is a consultant to Synthetic Biologics All authors are/were eligible for stock options None None None None None None 9 Gifts, ther Remuneration: JK-K, C, JS are Synthetic Biologics employees and CL, KG were employees at the time of the research

APDW 2016 Poster No. a90312

APDW 2016 Poster No. a90312 APDW 2016 Poster No. a90312 SYN-010, a Proprietary Modified-Release Formulation of Lovastatin Lactone, Lowered Breath Methane and Improved Stool Frequency in Patients with IBS-C Results of a multi-center,

More information

SECURITIES AND EXCHANGE COMMISSION Washington, D.C FORM 8-K CURRENT REPORT

SECURITIES AND EXCHANGE COMMISSION Washington, D.C FORM 8-K CURRENT REPORT SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported):

More information

CHOLESTAGEL 625 mg Genzyme

CHOLESTAGEL 625 mg Genzyme CHOLESTAGEL 625 mg Genzyme 1. NAME OF THE MEDICINAL PRODUCT Cholestagel 625 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 625 mg colesevelam hydrochloride (hereafter

More information

SIBO

SIBO SIBO What is it? Small Intestinal Bowel Overgrowth A chronic bacterial infection of the small intestine Caused by bad bacteria such as E Coli and Clostridium migrating to the small intestine There is not

More information

Small-Bowel and colon Transit. Mahsa Sh.Nezami October 2016

Small-Bowel and colon Transit. Mahsa Sh.Nezami October 2016 Small-Bowel and colon Transit Mahsa Sh.Nezami October 2016 Dyspeptic symptoms related to dysmotility originating from the small bowel or colon usually include : Abdominal pain Diarrhea Constipation However,

More information

Drugs for Bugs: The Next Generation of Pharmaceuticals

Drugs for Bugs: The Next Generation of Pharmaceuticals Drugs for Bugs: The Next Generation of Pharmaceuticals Mark Pimentel, MD, FRCP(C) Executive Director, Medically Associated Science and Technology (MAST) Program Cedars-Sinai Medical Center Microbiome The

More information

Irritable Bowel Syndrome: Last year FODMAPs, this year bile acids

Irritable Bowel Syndrome: Last year FODMAPs, this year bile acids Irritable Bowel Syndrome: Last year FODMAPs, this year bile acids Lana Bistritz, MD FRCPC Division of Gastroenterology Royal Alexandra Hospital Disclosures I have no financial conflicts of interest relevant

More information

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives:

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. SYNOPSIS Issue Date: 27 April 2009 Document No.: EDMS-PSDB-9908562:2.0 Name of Sponsor/Company Name of Finished Product Name of Active Ingredient Johnson & Johnson Pharmaceutical Research & Development,

More information

Unlocking the mysteries of gut comfort

Unlocking the mysteries of gut comfort Priority Research Programme Foods for improving gut function and comfort Unlocking the mysteries of gut comfort Nicole Roy, Professor AgResearch and Riddet Institute Host institution Foods for gut function

More information

New Developments in Irritable Bowel Syndrome

New Developments in Irritable Bowel Syndrome New Developments in Irritable Bowel Syndrome Mark Pimentel, MD, FRCP(C) Director, GI Motility Program Cedars-Sinai Medical Center IBS Forks in the Road Not all decisions in how to handle IBS made things

More information

Key words: breath tests; spot-methane breath test; diagnostic test; small intestinal bacterial overgrowth

Key words: breath tests; spot-methane breath test; diagnostic test; small intestinal bacterial overgrowth Gastroenterology Report, 5(3), 2017, 193 199 doi: 10.1093/gastro/gow048 Advance Access Publication Date: 27 January 2017 Original article ORIGINAL ARTICLE Selection of a cut-off for high- and low-methane

More information

Unlocking the mysteries of gut comfort

Unlocking the mysteries of gut comfort Priority Research Programme Foods for improving gut function and comfort Unlocking the mysteries of gut comfort Nicole Roy, Professor AgResearch and Riddet Institute Host institution Foods for gut function

More information

SINGLE-DOSE AND STEADY-STATE PHARMACOKINETICS OF MOXDUO, A DUAL-OPIOID FORMULATION CONTAINING A FIXED RATIO OF MORPHINE AND OXYCODONE

SINGLE-DOSE AND STEADY-STATE PHARMACOKINETICS OF MOXDUO, A DUAL-OPIOID FORMULATION CONTAINING A FIXED RATIO OF MORPHINE AND OXYCODONE #298 SINGLE-DOSE AND STEADY-STATE PHARMACOKINETICS OF MOXDUO, A DUAL-OPIOID FORMULATION CONTAINING A FIXED RATIO OF MORPHINE AND OXYCODONE LYNN WEBSTER, MD; 1 JOEL OWEN, PHD, RPH; 2 INGER DARLING, PHD;

More information

Gut Microbes: Systemic Disease. Mark Pimentel, MD. Cedars-Sinai Medical Center. Mark Pimentel, MD, FACG

Gut Microbes: Systemic Disease. Mark Pimentel, MD. Cedars-Sinai Medical Center. Mark Pimentel, MD, FACG Gut Microbes: Role in Health, IBS, GI and Systemic Disease Mark Pimentel, MD Director, GI Motility Program Cedars-Sinai Medical Center 1 Lacks cellulase cannot breakdown cellulose Depends completely on

More information

Study Centers: This study was conducted in 2 centers in Italy.

Study Centers: This study was conducted in 2 centers in Italy. Title of Trial: A randomised, double-blind, placebo-controlled, two-period, two-sequence-crossover interaction study to assess the effect of safinamide on levodopa pharmacokinetics in subjects with Parkinson

More information

BASIC PHARMACOKINETICS

BASIC PHARMACOKINETICS BASIC PHARMACOKINETICS MOHSEN A. HEDAYA CRC Press Taylor & Francis Croup Boca Raton London New York CRC Press is an imprint of the Taylor & Francis Group, an informa business Table of Contents Chapter

More information

Novel Broad-Spectrum b-lactamase Therapy to Protect the Gut Microbiome from Antibiotics

Novel Broad-Spectrum b-lactamase Therapy to Protect the Gut Microbiome from Antibiotics Novel Broad-Spectrum b-lactamase Therapy to Protect the Gut Microbiome from Antibiotics Sheila Connelly, PhD Vice President of Research ICETAR June 25, 2015 Slide 1 Importance of Intestinal Health Has

More information

Department of Clinical Pharmacology, Zhongshan Hospital, Fudan University, Shanghai , China

Department of Clinical Pharmacology, Zhongshan Hospital, Fudan University, Shanghai , China Biomedicine and Biotechnology Volume 2012, Article ID 386230, 4 pages doi:10.1155/2012/386230 Research Article The Difference in Pharmacokinetics and Pharmacodynamics between Extended-Release Fluvastatin

More information

Our evidence. Your expertise. SmartPill : The data you need to evaluate motility disorders.

Our evidence. Your expertise. SmartPill : The data you need to evaluate motility disorders. Our evidence. Your expertise. SmartPill : The data you need to evaluate motility disorders. SmartPill benefits your practice: Convenient performed right in your office Test standardization Provides direct

More information

Results. Subject Disposition and Demographics Of 37 enrolled subjects, 23 (62.2%) completed the study

Results. Subject Disposition and Demographics Of 37 enrolled subjects, 23 (62.2%) completed the study Poster 5-20 Effect of Gastric ph on the Bioavailability of in Healthy Subjects James Longstreth, PhD, Marijke H. Adams, PharmD, PhD, 2 Vasi Sperry, PhD, 3 Dan Kajdasz, PhD, 3 Carol R. Reed, MD 3 Longstreth

More information

Integrating Novel Diagnostic Strategies into Practice: Key Points. Stanley Cohen, MD Emory University Atlanta, Georgia

Integrating Novel Diagnostic Strategies into Practice: Key Points. Stanley Cohen, MD Emory University Atlanta, Georgia Integrating Novel Diagnostic Strategies into Practice: Key Points Stanley Cohen, MD Emory University Atlanta, Georgia Disclosure Research: Janssen, Covidien/Medtronics, AbbVie, AstraZeneca and QOL Speaker:

More information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the clinical

More information

Sponsor / Company: Sanofi Drug substance: SAR236553/REGN727 (alirocumab)

Sponsor / Company: Sanofi Drug substance: SAR236553/REGN727 (alirocumab) These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance:

More information

Japanese, Korean and Chinese subjects had also lived outside their respective countries for less than 10 years.

Japanese, Korean and Chinese subjects had also lived outside their respective countries for less than 10 years. The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

PFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See USPI

PFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See USPI PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.

More information

Small Bowel Obstruction after operation in a severely malnourished man. By: Ms Bounmark Phoumesy

Small Bowel Obstruction after operation in a severely malnourished man. By: Ms Bounmark Phoumesy Small Bowel Obstruction after operation in a severely malnourished man By: Ms Bounmark Phoumesy Normal length of GI tract Normal length(achieved by age 9) Small bowel 600cm (Men: 630 cm; Women: 592 cm)

More information

New Tests and Treatments for Dyspepsia and Irritable Bowel Syndrome

New Tests and Treatments for Dyspepsia and Irritable Bowel Syndrome New Tests and Treatments for Dyspepsia and Irritable Bowel Syndrome Soojong Hong Chae, MD Clinical Assistant Professor Digestive Diseases and Nutrition University of South Florida ROME III Functional dyspepsia

More information

Diagnosis and Management of Irritable Bowel Syndrome (IBS) For the Primary Care Provider

Diagnosis and Management of Irritable Bowel Syndrome (IBS) For the Primary Care Provider Diagnosis and Management of Irritable Bowel Syndrome (IBS) For the Primary Care Provider Elizabeth Coss, MD General Gastroenterologist Audie Murphy Veterans Hospital UT Health This presentation does not

More information

Effect of Lactobacillus reuteri (DSM 17938) on methane production in patients affected by functional constipation: a retrospective study

Effect of Lactobacillus reuteri (DSM 17938) on methane production in patients affected by functional constipation: a retrospective study European Review for Medical and Pharmacological Sciences 2017; 21: 1702-1708 Effect of Lactobacillus reuteri (DSM 17938) on methane in patients affected by functional constipation: a retrospective study

More information

Xifaxan. Xifaxan (rifaximin) Description

Xifaxan. Xifaxan (rifaximin) Description Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.34 Subject: Xifaxan Page: 1 of 6 Last Review Date: December 8, 2017 Xifaxan Description Xifaxan (rifaximin)

More information

NYSE MKT: SYN. FBR & Co. 2 nd Annual Healthcare Conference

NYSE MKT: SYN. FBR & Co. 2 nd Annual Healthcare Conference NYSE MKT: SYN FBR & Co. 2 nd Annual Healthcare Conference Boston, MA September 9, 2015 Forward-Looking Statements This presentation includes forward-looking statements on Synthetic Biologics current expectations

More information

IBS: overview and assessment of pain outcomes and implications for inclusion criteria

IBS: overview and assessment of pain outcomes and implications for inclusion criteria IBS: overview and assessment of pain outcomes and implications for inclusion criteria William D. Chey, MD Professor of Medicine University of Michigan What is the Irritable Bowel Syndrome Symptom based

More information

IBS The Physiologist s Perspective

IBS The Physiologist s Perspective IBS The Physiologist s Perspective Dr Anthony R. Hobson PhD Consultant Clinical Scientist, London The Functional Gut Clinic Reclaiming the F word The f-word functional has become a by-word for failure

More information

Revised European Guideline on PK and Clinical Evaluation of Modified Release Dosage Forms

Revised European Guideline on PK and Clinical Evaluation of Modified Release Dosage Forms 1st MENA Regulatory Conference on Bioequivalence, Biowaivers, Bioanalysis and Dissolution Jordan September 23 24, 2013 Revised European Guideline on PK and Clinical Evaluation of Modified Release Dosage

More information

Irritable bowel syndrome (IBS) is a functional gastrointestinal. Bacteria and the Role of Antibiotics in Irritable Bowel Syndrome INTRODUCTION

Irritable bowel syndrome (IBS) is a functional gastrointestinal. Bacteria and the Role of Antibiotics in Irritable Bowel Syndrome INTRODUCTION Bacteria and the Role of Antibiotics in Irritable Bowel Syndrome by Mark Pimentel Although several pathophysiologic models have been suggested, the etiology of irritable bowel syndrome (IBS) is unknown.

More information

ph Dependent Drug Delivery System: Review

ph Dependent Drug Delivery System: Review ph Dependent Drug Delivery System: Review Korake.S.P. SVERI s College of Pharmacy (Poly.), Pandharpur The ph-dependent CTDDS exploit the generally accepted view that ph of the human GIT increases progressively

More information

Corporate Medical Policy Fecal Microbiota Transplantation

Corporate Medical Policy Fecal Microbiota Transplantation Corporate Medical Policy Fecal Microbiota Transplantation File Name: Origination: Last CAP Review: Next CAP Review: Last Review: Fecal_microbiota_transplantation 7/2014 11/2017 11/2018 11/2017 Description

More information

NOTES: The Digestive System (Ch 14, part 2)

NOTES: The Digestive System (Ch 14, part 2) NOTES: The Digestive System (Ch 14, part 2) PANCREAS Structure of the pancreas: The pancreas produces PANCREATIC JUICE that is then secreted into a pancreatic duct. The PANCREATIC DUCT leads to the The

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

What is Dietary Fibre?

What is Dietary Fibre? Fibre What is Dietary Fibre? Non digestible part of plant foods Consists of one or more of edible CHO polymers and synthetic CHO polymers Types of Dietary Fiber There are many different types of fiber,

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Cholestagel 625 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 625 mg colesevelam

More information

William Chey, MD University of Michigan Ann Arbor, MI

William Chey, MD University of Michigan Ann Arbor, MI Lin Chang, MD David Geffen School of Medicine at UCLA Los Angeles, CA William Chey, MD University of Michigan Ann Arbor, MI Mark Pimentel, MD Cedars-Sinai Medical Center Los Angeles, CA Accredited by Jointly

More information

Holistic Healing Professional Practitioner Diploma Course Sample Pages Page 1

Holistic Healing Professional Practitioner Diploma Course Sample Pages Page 1 The last phase is called the intestinal phase and takes place about four hours after the gastric phase. The chyme passes through the small intestine, or duodenum, through the pyloric sphincter. This is

More information

Despicable Diarrhea. Darlene G. Kelly, MD, PhD Associate Professor of Medicine Medical Director HPN Program Mayo Clinic Rochester, Minnesota

Despicable Diarrhea. Darlene G. Kelly, MD, PhD Associate Professor of Medicine Medical Director HPN Program Mayo Clinic Rochester, Minnesota Despicable Diarrhea Darlene G. Kelly, MD, PhD Associate Professor of Medicine Medical Director HPN Program Mayo Clinic Rochester, Minnesota Conflict of Interest Statement Commercial Interests None Off

More information

Mipomersen (ISIS ) Page 2 of 1979 Clinical Study Report ISIS CS3

Mipomersen (ISIS ) Page 2 of 1979 Clinical Study Report ISIS CS3 (ISIS 301012) Page 2 of 1979 2 SYNOPSIS ISIS 301012-CS3 synopsis Page 1 Title of Study: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics,

More information

For more information about how to cite these materials visit

For more information about how to cite these materials visit Author: John Williams, M.D., Ph.D., 2009 License: Unless otherwise noted, this material is made available under the terms of the Creative Commons Attribution Non-commercial Share Alike 3.0 License: http://creativecommons.org/licenses/by-nc-sa/3.0/

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before

More information

Small Intestinal Bacterial Overgrowth-Symptoms, Diagnosis, and Treatment of Patients with Positive and Negative Results

Small Intestinal Bacterial Overgrowth-Symptoms, Diagnosis, and Treatment of Patients with Positive and Negative Results Small Intestinal Bacterial Overgrowth-Symptoms, Diagnosis, and Treatment of Patients with Positive and Negative Results Martin Carr, M.D. March 3, 2018 Good evening everyone, this is Martin Carr, and I

More information

ROLE OF THE GUT BACTERIA

ROLE OF THE GUT BACTERIA ROLE OF THE GUT BACTERIA Our Good Bacteria In a perfect world, we would all have a proper ratio of good bacteria And what could this proper ratio do for us? The knowledge of the connections between our

More information

Clinically proven to quickly relieve symptoms of common gastrointestinal disorders. TERRAGASTRO - Good health starts in the gut

Clinically proven to quickly relieve symptoms of common gastrointestinal disorders. TERRAGASTRO - Good health starts in the gut Clinically proven to quickly relieve symptoms of common gastrointestinal disorders GASTROINTESTINAL DISEASE Referred to as gastrointestinal diseases, they are common disorders which affect the esophagus,

More information

Effect of dietary fiber on intestinal gas production and small bowel transit time in man13

Effect of dietary fiber on intestinal gas production and small bowel transit time in man13 ffect of dietary fiber on intestinal gas production and small bowel transit time in man13 John H. Bond,4 M.D. and Michael D. Levitt,5 M.D. ABSTRACT The influence of dietary fiber on intestinal gas production

More information

Digestion. Text. What You Don t Know Can Hurt You!

Digestion. Text. What You Don t Know Can Hurt You! Digestion Text What You Don t Know Can Hurt You! Digestive Problems Approximately 36.5 million visits annually to ambulatory care facilities due to the diseases of the digestive system Over 4 million ulcers

More information

Amy-Jo Hooley Specialist Clinical Pharmacist

Amy-Jo Hooley Specialist Clinical Pharmacist Gut Decontamination Title of Guideline (must include the word Guideline (not protocol, policy, procedure etc) Contact Name and Job Title (author) Directorate & Speciality Guideline for the Safe Administration

More information

Study No: LOV OMA-104 Title : Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Statistical Methods

Study No: LOV OMA-104 Title : Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Statistical Methods The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Proton Pump Inhibitors do not Interact with the Immunosuppressant Enteric-Coated Mycophenolate Sodium

Proton Pump Inhibitors do not Interact with the Immunosuppressant Enteric-Coated Mycophenolate Sodium Proton Pump Inhibitors do not Interact with the Immunosuppressant Enteric-Coated Mycophenolate Sodium S. Kofler, C. Wolf, Z. Sisic, J. Behr, M. Vogeser, M. Shipkova, B. Meiser, G. Steinbeck, B. Reichart,

More information

HM2008/00566/00. study and to obtain clinical experience with the use of this drug. Primary Outcome/Efficacy Variable(s): <Pharmacokinetics>

HM2008/00566/00. study and to obtain clinical experience with the use of this drug. Primary Outcome/Efficacy Variable(s): <Pharmacokinetics> The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Effect of Multiple-Dose Ketoconazole and the Effect of Multiple-Dose Rifampin on Pharmacokinetics (PK) of the HCV NS3 Protease Inhibitor Asunaprevir

Effect of Multiple-Dose Ketoconazole and the Effect of Multiple-Dose Rifampin on Pharmacokinetics (PK) of the HCV NS3 Protease Inhibitor Asunaprevir Effect of Multiple-Dose Ketoconazole and the Effect of Multiple-Dose Rifampin on Pharmacokinetics (PK) of the HCV NS3 Protease Inhibitor Asunaprevir Eley T, 1 He B, 1 Huang S-P, 2 Stonier M, 1 Bedford

More information

Modulation of abdominal pain by probiotics. Anna Lyra, PhD DuPont Nutrition & Health

Modulation of abdominal pain by probiotics. Anna Lyra, PhD DuPont Nutrition & Health Modulation of abdominal pain by probiotics Anna Lyra, PhD DuPont Nutrition & Health Functional gastrointestinal (GI) wellbeing Up to 70% suffer from functional GI symptoms - ¾ do not seek medical care

More information

Presenter. Irritable Bowel Syndrome. Objectives. Introduction. Rome Criteria. Irritable Bowel Syndrome 2/28/2018

Presenter. Irritable Bowel Syndrome. Objectives. Introduction. Rome Criteria. Irritable Bowel Syndrome 2/28/2018 Presenter Irritable Bowel Syndrome Current evidence for diagnosis & management Julie Daniels DNP, CNM Assistant Professor Course Coordinator of Primary Care of Women Faculty at Frontier Nursing University

More information

Formulations and Availability 900 BILLION 5,319 HIGH POTENCY PROBIOTIC PEDIATRIC ADULT GERIATRIC PROVEN BY RESEARCH. HIGH-POTENCY. NO SHORTCUTS.

Formulations and Availability 900 BILLION 5,319 HIGH POTENCY PROBIOTIC PEDIATRIC ADULT GERIATRIC PROVEN BY RESEARCH. HIGH-POTENCY. NO SHORTCUTS. Formulations and Availability S TU D I E S PE R D I S E A S E 39 LIVER Liver Disease, Cirrhosis, Liver Failure, Hepatic Encephalopathy S TU D I E S PE R AG E G RO U P Visbiome Regular Product Code: 693-0412-01

More information

Biopharmaceutics Lecture-11 & 12. Pharmacokinetics of oral absorption

Biopharmaceutics Lecture-11 & 12. Pharmacokinetics of oral absorption Biopharmaceutics Lecture-11 & 12 Pharmacokinetics of oral absorption The systemic drug absorption from the gastrointestinal (GI) tract or from any other extravascular site is dependent on 1. 2. 3. In the

More information

Dietary fiber is defend as the edible parts of plant or analogous carbohydrates

Dietary fiber is defend as the edible parts of plant or analogous carbohydrates Chengcheng Jia NUTR 417 Supplement Paper The Soluble Dietary Fiber: Inulin Introduction and Supplement Background: Dietary fiber is defend as the edible parts of plant or analogous carbohydrates that are

More information

Probiotics in IBS. Dr. Partha Pratim Das Associate Professor Dhaka Medical college

Probiotics in IBS. Dr. Partha Pratim Das Associate Professor Dhaka Medical college Probiotics in IBS Dr. Partha Pratim Das Associate Professor Dhaka Medical college Definitions Probiotics: Live microorganisms that confer a health benefit on the host when administered in adequate amounts.

More information

Like every other part of the body gut bacteria can affect the thyroid and how it functions The information is preliminary Much of it is linking

Like every other part of the body gut bacteria can affect the thyroid and how it functions The information is preliminary Much of it is linking THYROID AND THE GUT Like every other part of the body gut bacteria can affect the thyroid and how it functions The information is preliminary Much of it is linking thyroid issues with abnormal gut bacteria

More information

Fecal Microbiota Transplantation

Fecal Microbiota Transplantation Protocol Fecal Microbiota Transplantation (20192) Medical Benefit Effective Date: 10/01/14 Next Review Date: 07/18 Preauthorization Yes Review Dates: 07/14, 07/15, 07/16, 07/17 Preauthorization is required.

More information

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment:

GSK Medicine: Study Number: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Emerging Treatments for IBS-C and Clinical Trial Endpoints

Emerging Treatments for IBS-C and Clinical Trial Endpoints Emerging Treatments for IBS-C and Clinical Trial Endpoints Lin Chang, M.D. Oppenheimer Family Center for Neurobiology of Stress David Geffen School of Medicine at UCLA Learning Objectives Describe current

More information

Slide 1 THYROID AND THE GUT. Slide 2. Slide 3 The Gut Affecting The Thyroid

Slide 1 THYROID AND THE GUT. Slide 2. Slide 3 The Gut Affecting The Thyroid Slide 1 THYROID AND THE GUT Slide 2 Like every other part of the body gut bacteria can affect the thyroid and how it functions The information is preliminary Much of it is linking thyroid issues with abnormal

More information

Nutritional assessments and diagnosis of digestive disorders

Nutritional assessments and diagnosis of digestive disorders Nutritional assessments and diagnosis of digestive disorders AASER ABDELAZIM Assistant professor of Medical Biochemistry Zagazig University, Egypt University of Bisha, KSA aaserabdelazim@yahoo.com 7 Mal

More information

Development of b-lactamase Therapies to Protect the Gut Microbiome from Antibiotics

Development of b-lactamase Therapies to Protect the Gut Microbiome from Antibiotics Development of b-lactamase Therapies to Protect the Gut Microbiome from Antibiotics Michael Kaleko, MD, PhD Senior Vice President of Research and Development BME July 13, 2015 Slide 1 Importance of Intestinal

More information

UNIT 5 MAINTENANCE SYSTEMS Digestive System Test Bank

UNIT 5 MAINTENANCE SYSTEMS Digestive System Test Bank UNIT 5 MAINTENANCE SYSTEMS Digestive System Test Bank Objective 5.01 Describe the basic functions of the digestive system. 1. What is the main function of the digestive system? a. Hold and receive food

More information

To assess safety profiles: significant laboratory changes and adverse events (AEs).

To assess safety profiles: significant laboratory changes and adverse events (AEs). These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor / Company: Sanofi Drug substance(s):

More information

Sponsor: Sanofi Drug substance(s): GZ316455

Sponsor: Sanofi Drug substance(s): GZ316455 These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription. Sponsor: Sanofi Drug substance(s):

More information

Digestion and Absorption

Digestion and Absorption Digestion and Absorption Digestion and Absorption Digestion is a process essential for the conversion of food into a small and simple form. Mechanical digestion by mastication and swallowing Chemical digestion

More information

Medical Policy. MP Ingestible ph and Pressure Capsule

Medical Policy. MP Ingestible ph and Pressure Capsule Medical Policy BCBSA Ref. Policy: 2.01.81 Last Review: 11/15/2018 Effective Date: 11/15/2018 Section: Medicine Related Policies 2.01.20 Esophageal ph Monitoring 6.01.33 Wireless Capsule Endoscopy as a

More information

Efficacy, Safety and Tolerability of 150 mg Q2W Dose of the PCSK9 mab REGN727/SAR236553: Data from Three Phase 2 Studies

Efficacy, Safety and Tolerability of 150 mg Q2W Dose of the PCSK9 mab REGN727/SAR236553: Data from Three Phase 2 Studies Efficacy, Safety and Tolerability of 150 mg Q2W Dose of the PCSK9 mab REGN727/SAR236553: Data from Three Phase 2 Studies Michael J. Koren, 1 Evan A. Stein, 2 Eli M. Roth, 3 James M. McKenney, 4 Dan Gipe,

More information

64a Pathology: Digestive System!

64a Pathology: Digestive System! 64a Pathology: Digestive System! 64a Pathology: Digestive System! Class Outline" 5 minutes" "Attendance, Breath of Arrival, and Reminders " 10 minutes "Lecture:" 25 minutes "Lecture:" 15 minutes "Active

More information

Product: Cinacalcet hydrochloride Clinical Study Report: Page 2 of 670

Product: Cinacalcet hydrochloride Clinical Study Report: Page 2 of 670 Page 2 of 670 2. SYNOPSIS Name of Sponsor: mgen Inc., Thousand Oaks, C Name of Finished Product: Cinacalcet hydrochloride (Sensipar, Mimpara ) Name of ctive Ingredient: cinacalcet (cinacalcet hydrochloride

More information

A novel microdose approach to assess bioavailability, intestinal absorption, gut metabolism, and hepatic clearance of simeprevir in healthy volunteers

A novel microdose approach to assess bioavailability, intestinal absorption, gut metabolism, and hepatic clearance of simeprevir in healthy volunteers A novel microdose approach to assess bioavailability, intestinal absorption, gut metabolism, and hepatic clearance of simeprevir in healthy volunteers Sivi Ouwerkerk-Mahadevan, 1 Jan Snoeys, 1 Alex Simion,

More information

Clinical Trials A Practical Guide to Design, Analysis, and Reporting

Clinical Trials A Practical Guide to Design, Analysis, and Reporting Clinical Trials A Practical Guide to Design, Analysis, and Reporting Duolao Wang, PhD Ameet Bakhai, MBBS, MRCP Statistician Cardiologist Clinical Trials A Practical Guide to Design, Analysis, and Reporting

More information

Disorders in which symptoms cannot be explained by the presence of structural or tissue abnormalities Irritable bowel syndrome Functional heartburn Functional dyspepsia Functional constipation Functional

More information

Bioequivalence Study of Sildenafil 20 mg Tablets in Healthy Thai Male Volunteers

Bioequivalence Study of Sildenafil 20 mg Tablets in Healthy Thai Male Volunteers Original Article Mahidol University Journal of Pharmaceutical Sciences 2014; 41 (2), 1-6 Bioequivalence Study of Sildenafil 20 mg Tablets in Healthy Thai Male Volunteers B. Chuasuwan 1*, P. Ratnatilaka

More information

Development of Canagliflozin: Mechanistic Absorption Modeling During Late-Stage Formulation and Process Optimization

Development of Canagliflozin: Mechanistic Absorption Modeling During Late-Stage Formulation and Process Optimization Development of Canagliflozin: Mechanistic Absorption Modeling During Late-Stage Formulation and Process Optimization Nico Holmstock Scientist, Janssen R&D M CERSI 2017, BALTIMORE (USA) Canagliflozin An

More information

NIH Public Access Author Manuscript Transplant Proc. Author manuscript; available in PMC 2010 September 22.

NIH Public Access Author Manuscript Transplant Proc. Author manuscript; available in PMC 2010 September 22. NIH Public Access Author Manuscript Published in final edited form as: Transplant Proc. 1990 February ; 22(1): 57 59. Effect of Hepatic Dysfunction and T Tube Clamping on FK 506 Pharmacokinetics and Trough

More information

Triple sugar screen breath hydrogen test for sugar intolerance in children with functional abdominal symptoms

Triple sugar screen breath hydrogen test for sugar intolerance in children with functional abdominal symptoms Indian J Gastroenterol (2010) 29:196 200 DOI 10.1007/s12664-010-0055-7 ORIGINAL ARTICLE Triple sugar screen breath hydrogen test for sugar intolerance in children with functional abdominal symptoms Jonathan

More information

Section 5.2: Pharmacokinetic properties

Section 5.2: Pharmacokinetic properties Section 5.2: Pharmacokinetic properties SmPC training presentation Note: for full information refer to the European Commission s Guideline on summary of product characteristics (SmPC) SmPC Advisory Group

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical

More information

INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER

INDIVIDUAL STUDY TABLE REFERRING TO PART OF THE DOSSIER 2. SYNOPSIS Title of Study: An Open-Label, 2-Cohort Study to Evaluate the 2-Way Interaction Between Multiple Doses of and a Single Dose of Rosuvastatin (Crestor ), to Assess the Dose Proportionality of,

More information

Study Code: Date: 27 July 2007

Study Code: Date: 27 July 2007 These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: Generic drug name:

More information

2- Minimum toxic concentration (MTC): The drug concentration needed to just produce a toxic effect.

2- Minimum toxic concentration (MTC): The drug concentration needed to just produce a toxic effect. BIOPHARMACEUTICS Drug Product Performance Parameters: 1- Minimum effective concentration (MEC): The minimum concentration of drug needed at the receptors to produce the desired pharmacologic effect. 2-

More information

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only.

The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. The clinical trial information provided in this public disclosure synopsis is supplied for informational purposes only. Please note that the results reported in any single trial may not reflect the overall

More information

Carbohydrates. Lecture2

Carbohydrates. Lecture2 Carbohydrates Lecture2 Disaccharides Consist of two monosaccharides covalently bound to each other. All of which are isomers with the molecular formula C 12 22 O 11. The differences in these disaccharides

More information

Subjects from the Safety Population who had GSK PK parameter estimates from any portion of the study. Cohort 1 (N=8)

Subjects from the Safety Population who had GSK PK parameter estimates from any portion of the study. Cohort 1 (N=8) The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of

More information

Clinical Study Synopsis for Public Disclosure

Clinical Study Synopsis for Public Disclosure abcd Clinical Study for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis - which is part of the clinical

More information

SYNOPSIS OF RESEARCH REPORT (PROTOCOL BC20779)

SYNOPSIS OF RESEARCH REPORT (PROTOCOL BC20779) TITLE OF THE STUDY / REPORT No. / DATE OF REPORT INVESTIGATORS / CENTERS AND COUNTRIES Clinical Study Report Protocol BC20779: Multicenter, double-blind, randomized, placebo-controlled, dose ranging phase

More information

Physiology of the gut and mechanisms of prebiotic effect. Joanne Slavin, Ph.D, R.D. Department of Food Science and Nutrition University of Minnesota

Physiology of the gut and mechanisms of prebiotic effect. Joanne Slavin, Ph.D, R.D. Department of Food Science and Nutrition University of Minnesota Physiology of the gut and mechanisms of prebiotic effect Joanne Slavin, Ph.D, R.D. Department of Food Science and Nutrition University of Minnesota Fermentable carbohydrate: GI Tract Incompletely digested

More information

UBS Global Healthcare Conference May 19, 2014

UBS Global Healthcare Conference May 19, 2014 UBS Global Healthcare Conference May 19, 2014 Safe Harbor Statement This presentation may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section

More information

TRANSPARENCY COMMITTEE OPINION. 13 December 2006

TRANSPARENCY COMMITTEE OPINION. 13 December 2006 The legally binding text is the original French version TRANSPARENCY COMMITTEE OPINION 13 December 2006 HELIKIT 75 mg, powder for oral solution CIP : 343 132-1 Applicant : MAYOLY SPINDLER 13 Curea anhydrous

More information