Clinical Trial List

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Valentine Perkins
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1 Clinical Trial List Service Driven. Quality Focused. Global Perspective.

2 Clinical Trial List Pharmacokinetic A Two-Period, Single Dose Pharmacokinetic Study of Three Sustained-Release Antiviral Formulations Compared with the Innovator Immediate-Release Tablet Assessment of the Bioavailability from Four New Tablet Prototype Formulations Relative to the Currently Approved Capsules in Healthy Subjects of an Existing Antiviral Treatment 20 Healthy Males 32 Healthy Males Virology Oral Approved FDA Virology Oral Approved FDA A Bioequivalence Trial of an Oral and Intravenously Administered Chemotherapy Agent in Oncology Patients 7 Patients with Primary CNS Malignancies Oncology Infusion and Oral Approved FDA/ A Pilot Study to Evaluate the Bioavailability of a New Drug for Rheumatoid Arthritis Administered as a Solid Dosage Formulation Relative to a Suspension Formulation Selection Study in Young Healthy Comparing Three Sustained-Release Formulations with the Brand Leader Immediate-Release Tablets on Pharmacokinetic and Safety Criteria of an Existing Antiviral Drug Using a Randomised, Open Label, Four-Period, Crossover Design An Open-label, Randomised, Four-Period Crossover Study in Healthy to Compare the Relative Bioavailability of Four Amphetamine Formulations 36 Healthy Male 20 Healthy Male and Female 16 Healthy Male and Female Rheumatology Oral Suspension New FDA Oncology Oral Existing FDA Neurology Oral Existing FDA An Open-Label, Cross-Over, Single-Dose, Bioavailability Study Comparing New Optimized Soft Gelatin Capsule Versus the Reference Capsule of a New Anxiolytic in Healthy Subjects 20 Healthy Male CNS Oral New FDA/ Relative Bioavailability of Four Prototype Formulations of a New Anxioloytic in Comparison to the Reference Phase 1 Capsule Formulation, After Single Oral Under Fasting and Fed Conditions to Healthy Male Subjects 68 Healthy Male CNS Oral New FDA/ An Open-Label, Two-Period, Two-Cohort Study to Evaluate the Potential Pharmacokinetic Interaction of a Co-Administered New for Nausea with Nifedipine 10 mg in Healthy Subjects Single-Dose Pharmacokinetics of Four Novel Oral Formulations of a New Anxiolytic in Healthy Male Administered Under Fasting and Fed Conditions Relative Bioavailability of Four Oral Prototype Formulations of a New Obesity Drug Under Fasting and Fed Conditions to Healthy Subjects Pharmacodynamic and Pharmacokinetic Evaluation of a Novel Orally Administered Sustained Release Treatment for Chronic Spasticity 28 Healthy Male and Female 48 Healthy Male 24 Healthy Male 32 Healthy Male and Female CNS Oral New FDA CNS Oral New FDA Endocrinology Oral New FDA CNS Oral New Formulation FDA Absolute Bioavailability Study Comparing an IV Anaesthetic with a Transdermal Anaesthetic Agent 8 Healthy Male and Female CNS IV Infusion and Transdermal Patch New Formulation FDA Effects of Cytochrome P450 Inhibition by a New Orally Administered on the Metabolism of Midazolam and Tolbutamide 24 Healthy Male and Female Rheumatology Oral Suspaension New FDA

3 2 Clinical Trial List Pharmacokinetic - Inhaled A Pharmacokinetic and Bioavailability Study of a New Treatment for Cystic Fibrosis Using Normal Subjects 16 Healthy Males Respiratory Inhaled New Use of an Existing FDA A Multicentre, Open-Label, Single-Arm, Proof-of-Concept Study to Evaluate the Safety, Tolerability, and Effect on Sputum Pseudomonas Aeruginosa Density of an Inhaled Antibody in Adult Patients with Cystic Fibrosis 5 Males and Females with Cystic Fibrosis Respiratory Inhaled Existing FDA Three Way Crossover Study of an Inhaled, IV and Oral Formulation of a New Treatment for Cystic Fibrosis in Healthy 18 Healthy Male Respiratory IV, Inhaled and Oral Approved FDA/ A Randomised, Open-Label, Active Controlled, 3 Arm, 3 Period, Crossover, Safety and Dose Response Study Investigating the Pharmacokinetics and Pharmacodynamics of Inhaled Combination Therapy in Adult Asthmatic Subjects 18 Mild To Moderate Asthmatics Respiratory Inhalation Existing FDA An Open-Label Trial to Assess the Safety and Tolerability of a Combination Antibiotic in Subjects with Bronchiectasis or Cystic Fibrosis Cystic Fibrosis Bronchiectasis Respiratory Inhalation Existing FDA Males Pharmacokinetic - Transdermal A Proof of Concept Pharmacokinetic Trial of a Parkinson s Treatment Delivered Via a Metered Dose Transdermal Delivery System A Phase I, Clinical Trial to Determine the Pharmacokinetics of Different Formulations of a Combined Contraception Admnistered Transdermally 8 Healthy Male 24 Healthy Post Menopausal Women CNS Transdermal Existing Reproduction Transdermal Existing Transdermal Drug Delivery of a Peptide Utilising a Novel Penetration Enhancer 20 Healthy Male Endocrinology Topical Biological Protocol Preparation,, Final Report, Commercial Sponsorship Assessment of the Transdermal Absorption and Pharmacodynamics of a Treatment for Osteoporosis 36 Post Menopausal Women Endocrinology Transdermal New Transdermal Drug Delivery System Assessment of the Transdermal Absorption and Pharmacodynamics of a Treatment for Osteoporosis (New Concentration) 36 Post Menopausal Women Endocrinology New Transdermal Drug Delivery System Existing FDA Assessment of the Transdermal Absorption and Pharmacodynamics of a Treatment for Cardiac Failure 12 Healthy Male Cardiovascular New Transdermal Drug Delivery System Existing FDA

4 4 Clinical Trial List First Time in Human A Phase I, Single Centre, Double-Blind, Placebo-Controlled, Single Dose Escalation Safety and Tolerability Trial with a New Oral for RSV 72 Healthy Males Virology Oral New FDA/ A Phase I, Single Dose, Double-Blind, Randomised, Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of a Novel Neuroprotective when Administered as a Bolus Injection Immediately Followed by a 12, 24 or 72 Hour Infusion 28 Healthy Males CNS Infusion New FDA/ A Phase I, Single-Centre, Placebo Controlled, Dose-Escalating Study of the Safety and Pharmacokinetics of a New Drug for the Treatment of HCV in Healthy Male Administered Orally in the Fasted and Fed State 40 Healthy Males Virology Oral Suspension New Protocol Preparation, A Phase I, Single-Centre, Placebo Controlled, Dose-Escalating Study of the Safety and Pharmacokinetics of a New Peptide Drug in Healthy and Exercise/Diet Controlled Type 2 Diabetics Healthy Males Exercise/Diet Controlled Type 2 Diabetes Endocrinology Oral Suspension New FDA Protocol Preparation, A Phase I, Single-Centre, Randomised, Single-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Tolerability, Safety, and Pharmacokinetics of an Intravenous Infusion of a Novel Anti-Inflammatory Administered to Healthy Adult Male A Phase I, Randomised, Single-Blind, Placebo-Controlled, Single-Centre, Dose Escalation Study of a Bolus Injection of New for Myocardial Reperfusion Damage A Randomised, Third Party Blind, Crossover Study of the Efficacy of a New to Reduce the Frequency and Severity of Akathisias Due to Neuroleptic Therapy in Healthy Placebo-Controlled, Ascending Single- and Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of a New Compound for High Cholesterol in Healthy Subjects Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Oncology Drug in Healthy Subjects 32 Healthy Male 32 Healthy Male 24 Healthy Male 64 Healthy Male 56 Healthy Male Respiratory Infusion New FDA Cardiovascular Infusion New FDA, Pharmokinetic Processing (Derivitization) CNS Oral New FDA Cardiovascular Oral New FDA Oncology Oral New FDA A Phase I, Single-Centre, Double-Blind, Placebo-Controlled, Escalating Single Oral Dose, Safety and Tolerability Clinical Trial with a New Antiviral in Healthy Subjects 72 Healthy Male Virology Oral New FDA/ Single Ascending Dose Study in Healthy Male with a New Topical Anaesthetic Agent 35 Healthy Male CNS Topical New FDA/

5 6 Clinical Trial List First Time in Human Multiple Ascending Intravenous Dose of a Novel Anti-Inflammatory Agent in Healthy Male Single Ascending Dose of a Novel Neuroprotective Agent in Healthy Male when Administered as a Five Minute and 12 Hour Infusion Single Ascending Intravenous Dose of a Novel Anti-inflammatory in Moderate Crohn s Disease Patients 24 Healthy Male 35 Healthy Male 20 Crohn s Disease Patients Gastroenterology Oral New FDA CNS IV Infusion New FDA Gastroenterology SC Injection Biological FDA Open Label Pharmacokinetic Study of a Novel Protease Inhibitor in Healthy Males when Administered with or without Ritonavir 12 Healthy Male Virology Oral New FDA/ An Open Label Study with a New Topical Product for the Treatment of Onychomycosis of the Great Toe 35 Onychomycosis Patients Infectious Disease Topical New Formulation FDA Phase I Study of a Novel Orally Administered Antiviral Treatment for Hepatitis C 20 Hepatitis C Infected Subjects Virology Oral New FDA First Time In Human - Biological A Randomised, Double-Blind, Placebo-Controlled, Ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a New Biological After Multiple Dose s in Subjects with Moderate to Severe Psoriasis A Phase 1 Randomised Double-Blind, Placebo-Controlled, Single Dose, Dose Escalation Study of a New Monoclonal Antibody for Rheumatoid Arthritis in Healthy 20 Psoriasis Patients with >10%BSA & Biological Naive 12 Healthy Male Dermatology SC Injection New Biological FDA Rheumatology SC Injection New Biological FDA Single Ascending Dose Study in Healthy Followed by a Multiple Dose Study in Mild to Moderate Asthmatics of a New Monoclonal Antibody for Asthma Healthy Male Mild To Moderate Asthmatics Respiratory IV New Biological FDA Single Ascending Dose Study in Healthy Male with a New Monoclonal Antibody for Rheumatoid Arthritis 63 Healthy Male Rheumatology IV Biological FDA/ A First in Patient Single Ascending Dose Study of a New Biological Drug for the Treatment of Rheumatoid Arthritis 20 RA Patients on Stable Doses of Methotrexate not Previously Received any Biological Agents Rheumatology IV Biological FDA/ Single Ascending Dose of a Novel Intravenous Anti-Inflammatory Agent in Healthy Male 40 Healthy Male Dermatology SC Injection and IV Infusion (Final Cohort) Biological FDA

6 8 Clinical Trial List First Time In Human - Biological Multiple Ascending Dose of a Novel Anti-Inflammatory Biological in Mild to Moderate Asthmatics 20 Mild to Moderate Asthmatics Respiratory SC Injection and IV Infusion Biological FDA Double Blind Ascending Safety and Pharmacokinetic Study of a Novel Subcutaneously Delivered Biological in Development for the Treatment of Inflammatory Diseases 36 Healthy Male Rheumatology SC Injection New Biological FDA/ First Time In Human - Inhaled A Randomised, Double Blind, Placebo Controlled, Parallel Group, 14 Day Repeat Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Inhaled Steroid 32 Healthy Males Respiratory Inhaled New FDA Special Studies Category Subects Subjects Therapeutic Area Route Of Compound Type Nucleus Network A Double-Blind, Randomised, Placebo-Controlled, Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Migraine Drug in Healthy Male Subjects Ethno- Pharmacology Bridging Study 16 8 Caucasian Healthy Males, Weight and Aged Matched CNS Oral New M.O.H A Double-Blind, Randomised, Placebo Controlled, Alternating Panel, Single Oral Rising Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of a Drug for the Prevention of Heart Disease in Healthy Young Male Participants Ethno- Pharmacology Bridging Study 16 Healthy Male Cardiovascular Oral New M.O.H Versus Caucasian Study to Investigate the Pharmacokinetics of Various Capsule Formulations of a New Compound for Migraine Ethno- Pharmacology Bridging Study 16 8 Caucasian Healthy Males, Weight and Aged Matched CNS Oral New FDA/ M.O.H Phase III Study of a New Vaccine for Encephalitis Vaccine 60 Healthy Male and Female Infectious Disease SC Injection Vaccine FDA IECSubmission, A Phase II Clinical Trial in Coronary Artery Bypass Graft Surgery Patients with a Novel Neuro Protective Agent Phase II 10 Coronary Artery Bypass Graft Patients CNS 4 hour IV Infusion New FDA, Commercial Sponsorship

7 , Burnet Tower, AMREP Precinct Business Address 5th Floor, Burnet Tower, AMREP Precinct 89 Commercial Road Melbourne, Victoria, Australia 3004 Tel Fax Fax Mailing Address PO Box 6083 St Kilda Road Central Melbourne, Victoria, Australia 8008, Harold Stokes Building, Austin Site Business Address C/O Austin Centre for Clinical Studies Levels 8 and 9, Harold Stokes Building 145 Studley Road Heidelberg, Victoria, Australia 3004 Tel Fax Mailing Address PO Box 5555 Heidelberg, Victoria, Australia contactus@nucleusnetwork.com.au Ltd ABN trading as Centre for Clinical Studies, Clinical Trials Consulting, Education and in association with its network partners.

Cognitive Research Corporation

Cognitive Research Corporation Contract Research Organization offering specialized expertise to fit the unique needs of each client Bobbie Theodore clinicaltrials@alliancesites.com An Alliance of Quality