Clinical Study Synopsis

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1 Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. 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 making any decisions on their treatment. Healthcare Professionals should always refer to the specific labeling information approved for the patient's country or region. Data in this document or on the related website should not be considered as prescribing advice. The study listed may include approved and non-approved formulations or treatment regimens. Data may differ from published or presented data and are a reflection of the limited information provided here. The results from a single trial need to be considered in the context of the totality of the available clinical research results for a drug. The results from a single study may not reflect the overall results for a drug. The following information is the property of Bayer HealthCare AG. Reproduction of all or part of this report is strictly prohibited without prior written permission from Bayer HealthCare AG. Commercial use of the information is only possible with the written permission of the proprietor and is subject to a license fee. Please note that the General Conditions of Use and the Privacy Statement of bayerhealthcare.com apply to the contents of this file.

2 Study Sponsor: Study Number: Study Phase: I Clinical Trial Results Synopsis Bayer HealthCare AG Study Design Description Official Study Title: Randomized study in a 3-fold crossover, single-dose design to investigate the pharmacokinetics of a 20 mg vardenafil extended-release pellet formulation in the fed and fasted condition, respectively, in comparison to a 20 mg standard Levitra tablet in healthy male subjects Therapeutic Area: Urology Test Product Name of Test Product: Name of Active Ingredient: Dose and Mode of Administration: Vardenafil fumarate extended-release pellet Vardenafil fumarate Treatment A: Single oral dose of vardenafil 20 mg extended-release (ER) pellets (dose referring to vardenafil base) (Development No. 204) taken in the fasted state. Reference Therapy/Placebo Treatment B: Single oral dose of vardenafil 20 mg ER pellets (dose referring to vardenafil base) (Development No. 204) taken 30 minutes after start of a standardized high-fat, high-calorie American breakfast respectively which was eaten within 30 min or less. Reference Therapy: Vardenafil Hydrochloride (HCl) (Levitra, BAY ) immediate-release tablet Dose and Mode of Administration: Treatment C: Single oral dose of vardenafil (Levitra 20 mg) 20 mg immediate-release (IR) tablet (dose referring to vardenafil base) taken in the fasted state. Duration of Treatment: Single doses of all the three treatments; 3 single doses with a washout of at least 4 days Studied period: Date of first subjects first visit: 13 JUN 2008 Date of last subjects last visit: 28 JUL 2008 Premature Study Suspension / Termination: Substantial Study Protocol Amendments: No Amendment no. 1 (dated 06 MAY 2008) specified that the ER pellet formulation contains vardenafil as fumarate and not as hydrochloride. Study Centre(s): The study was conducted at a single center in Germany. Methodology: The study comprised of 5 phases: Screening phase, 3 treatment periods, and a follow-up phase. The subjects were admitted to the ward prior to the day of drug administration. The test drug was administered as single dose in the morning of the corresponding profile day (Day 00d) after a fasting period of at least 10 hours or 30 min after start of a standardized high-fat, high-calorie breakfast. The reference drug was administered as single dose in the morning of the Page 1 of 9

3 Indication/ Main Inclusion Criteria: corresponding profile day (Day 00d) after a fasting period of at least 10 hours. Study drug was administered together with 240 ml of nonsparkling water. Subjects remained in-house from Day -01d until the evening of Day 01d in all 3 study periods. The study periods were separated by a wash-out phase of at least 4 days between treatments. The final examination was performed approximately 1 week after the last administration of study drug. The overall time period of blood sampling for pharmacokinetic parameters was from 0h to 36h. Indication: Study Objectives: Overall: Main Inclusion Criteria: Healthy, White, male subjects aged years, body mass index between 18 and 29.9 kg/m 2 (inclusive) Primary: To investigate the pharmacokinetics of a 20 mg vardenafil extended-release (ER) pellet formulation in the fed and fasted states compared to a standard Levitra tablet in healthy male subjects. Secondary: To investigate safety and tolerability of these treatments. Evaluation Criteria: Efficacy (Primary): Efficacy (Secondary): Statistical Methods: Efficacy (Primary): Safety: Adverse events, vital signs, electrocardiogram (ECG), laboratory parameters, physical examination, and subjective well-being. Pharmacokinetics: Based on the plasma concentration vs time data of vardenafil and its metabolite BAY , the following pharmacokinetic parameters were calculated: Primary parameters: AUC, Cmax, frel [(vardenafil ER fasted/vardenafil IR fasted) and (vardenafil ER fed/vardenafil ER fasted)], AUC(0-tn) was planned to be primary if mean AUC(tn- ) exceeded 20% of AUC Secondary parameters: AUC(0-tn) (unless primary), AUCnorm, AUC/D, Cmax,norm, Cmax/D, C(24)/Cmax, CL/f, MRT, tmax, t1/2 Other parameters: AUC(tn- ), points terminal. Efficacy (Secondary): Page 2 of 9

4 Number of Subjects: Safety: The incidence of treatment-emergent adverse events was summarized by treatment using Medical Dictionary for Regulatory Activities (MedDRA) preferred terms. Pharmacokinetics: The logarithms of AUC, AUC(0-tn), and Cmax were analyzed using an analysis of variance (ANOVA) including sequence, subject(sequence), period, and treatment effects. Based on these analyses, point estimates (geometric LS-means) and exploratory 90% confidence intervals for the ratios "Treatment A/Treatment C" and "Treatment B/Treatment A" were calculated by re-transformation of the logarithmic data using the intra-individual standard deviation of the ANOVA. Enrolled: 15 subjects Safety analyses: 14 subjects Pharmacokinetic (PK) analyses: 13 subjects Study Results Results Summary Subject Disposition and Baseline A total of 15 healthy male subjects were enrolled into the study. One subject did not receive any study medication due to elevated creatine kinase (CK) before start of medication. Thus, 14 subjects were valid for safety. Another subject withdrew his consent in the third period prior to dosing. All other 13 subjects completed the study without major changes versus protocol and were valid for PK. The mean age of the 14 subjects valid for safety was 34.6 years (range: 21.0 to 48.0 years), mean BMI was 25.9 kg/m 2 (range: kg/m 2 ). Results Summary Efficacy Page 3 of 9

5 Results Summary Safety Number of subjects with treatment-emergent adverse events by MedDRA primary system organ class and preferred term are displayed in Table 1. Table 1: Number of subjects with treatment-emergent adverse events by MedDRA primary system organ class and preferred term (all subjects valid for safety, n=14) The treatment-emergent, drug-related adverse events with subject number and worst severity are displayed in Table 2. Page 4 of 9

6 Table 2: Incidence of treatment-emergent, drug-related adverse events with subject number and worst severity (all subjects valid for safety, n=14) Twelve of 14 subjects valid for safety analysis reported at least 1 treatment-emergent adverse event during any of the 3 study periods. All treatment-emergent adverse events were of mild or moderate intensity. Moderate treatment-emergent adverse events were headache (n=4), nausea (n=1), and cough (n=1). The most frequent treatment-emergent adverse events were headache, nasal congestion, and flushing. The most frequent treatment-emergent, drug-related adverse events were headache, nasal congestion, and flushing. Three subjects experienced moderate drug-related headache during any of the 3 study periods. Treatment-emergent, drug-related headache occurred in 2, 4, and 5 subjects after single oral 20 mg doses of vardenafil ER in the fasting condition, vardenafil ER in the fed condition, and Levitra in the fasting condition, respectively. Moderate drug-related headache occurred in 1, 2, and 1 subjects, respectively, all other events of drug-related headache were mild. Mild drug-related flushing occurred only after Levitra administration. Thus, concerning the wellknown drug-related adverse events of vardenafil such as headache and flushing, vardenafil ER showed a better tolerability as compared to Levitra. There were no deaths or other serious or significant adverse events reported in this study. No clinically relevant increases in laboratory values were determined during the course of this study. No clinically relevant influence of vardenafil on ECG parameters including QT and QTc was detected in any subject following single oral doses of 20 mg. No subject showed a QTc value (Bazett and Fridericia) >450 ms at any time during this study. During the course of the Page 5 of 9

7 study, there were 6 subjects with a QTc (Bazett) value >30-60 ms. No subject had a QTc (Fridericia) value >30 ms. Results Summary Pharmacokinetics Table 3 and Table 4 summarize the results as geometric means and coefficients of variation as well as ranges of the pharmacokinetic parameters for vardenafil and its metabolite M1 (BAY ) by treatment. Table 3: Pharmacokinetic parameters of vardenafil in plasma following a single oral dose of 20 mg vardenafil (geometric mean/%cv(range), all subjects valid for PK, n=13) Page 6 of 9

8 Table 4: Pharmacokinetic parameters of BAY in plasma following a single oral dose of 20 mg vardenafil, respectively (geometric mean/%cv(range), all subjects valid for PK, n=13) The influence of a standardized high-fat and high-calorie American breakfast on the pharmacokinetics of the vardenafil ER pellet formulation was assessed by the ratio "fed/fasting" (B/A) of AUC, AUC(0-tn) and Cmax. Moreover, AUC, AUC(0-tn), and Cmax of the vardenafil ER pellet formulation and Levitra standard IR tablet were compared (A/C) (Table 5 and Table 6). Page 7 of 9

9 Table 5: Point estimators (LS-means) and 2-sided 90% confidence intervals for the ratios of the primary parameters AUC and Cmax of vardenafil (results of ANOVA, all subjects valid for PK, n=13) Table 6: Point estimators (LS-means) and 2-sided 90% confidence intervals for the ratios of the primary parameters AUC and Cmax of BAY (results of ANOVA, all subjects valid for PK, n=13) Vardenafil 20 mg ER pellet formulation 204 was characterized by moderate inter-subject variability in the fasted and fed states in comparison to the marketed Levitra 20 mg IR tablet (geometric %CV of AUC: approximately 48% after Treatments A and B versus 62% after Treatment C, Table 3). AUC, AUC(0-tn) and Cmax for vardenafil ER were very similar in the fed and fasted state ("B/A" ratio, Table 5). The upper limits of the 90% confidence intervals of the ratio "B/A" only slightly exceeded the bioequivalence range. As a result of delayed gastric emptying the rate of absorption was reduced with food and median vardenafil tmax was increased in the fed (4 hours) compared to fasting condition (1.5 hours). In conclusion, the influence of a standardized high-fat and high-calorie American breakfast on the pharmacokinetics of the vardenafil ER pellet formulation was minimal. In the fasted state, the Cmax and AUC (LS-mean) for the vardenafil ER pellet formulation (Treatment A) were equal to 14% and 56%, respectively, of 20 mg Levitra IR tablet (Treatment C) ("A/C" ratio, Table 5). The mean residence time (MRT) was markedly prolonged with the ER formulation (15 hours, fasting) compared to vardenafil IR (5 hours, fasting). Likewise, another pharmacokinetic parameter specifically characterizing controlledrelease properties i.e., the ratio of concentrations at 24 hours over Cmax (C(24)/Cmax) was greatly increased with vardenafil ER (21%, fasting) compared to Levitra tablet (0.5%, fasting). Moreover, the apparent elimination half-life of vardenafil ER (6.3 hours, fasting) was slightly increased over the IR formulation (5 hours, fasting) indicating absorption-limited elimination with the pellet formulation. Page 8 of 9

10 The metabolite BAY displayed a pharmacokinetic pattern comparable to the parent compound. However, its extent of formation was decreased following administration of the ER formulation compared to the immediate-release tablet [ratio of AUC(0-tn) BAY /vardenafil = 68% (ER fasting) vs 101% (IR fasting)]. This is likely to be attributable to the decreased expression of the metabolizing enzyme cytochrome (CYP) 3A4 in more distal parts of the gastrointestinal tract where portions of the vardenafil dose are absorbed after administration of the ER formulation. Conclusion(s) In conclusion, vardenafil 20 mg ER pellet formulation 204 showed virtually identical bioavailability in the fasting state and after a standardized high-fat and high-calorie American breakfast. The overall extent of exposure following the vardenafil 20 mg ER pellet formulation was approximately half of that after a Levitra 20 mg IR tablet indicating a relevant reduction in bioavailability. Mean Cmax for vardenafil was low (mean: 14%; range: 3-37% compared to Levitra 20 mg IR tablet) and typical "controlled-release" parameters such as MRT, C(24)/Cmax, and t1/2 were increased after the ER pellet formulation compared to the Levitra IR tablet. Single oral doses of 20 mg vardenafil were safe and well tolerated. Concerning the wellknown drug-related adverse events of vardenafil such as headache and flushing, vardenafil ER showed a better tolerability compared to Levitra. Date Created or Date Last Updated: Publication(s): None 24 APR 2012 Date of Clinical Study Report: 20 AUG 2009 Page 9 of 9

11 Marketing Authorization Holder in Germany Appendix to Clinical Study Synopsis for study Investigational Site List Name Bayer Pharma AG Postal Address D Berlin Deutschland Sponsor in Germany Legal Entity Name Bayer HealthCare AG Postal Address D Leverkusen, Germany List of Investigational Sites No Facility Name Street ZIP Code City Country 1 MEDA Manufacturing GmbH, ClinPharmCologne MEDA Manufacturing GmbH ClinPharmCologne Neurather Ring Köln GERMANY Page 1 of 1

12 Appendix to Clinical Study Synopsis Product Identification Information Product Type US Brand/Trade Name(s) Brand/Trade Name(s) ex-us Generic Name Main Product Company Code Drug Levitra, STAXYN Levitra, Vivanza, Yaila, Levitra 10mg orodispersible tablets, STAXYN, Vardenafil BAY Other Company Code(s) Chemical Description Other Product Aliases Vardenafil: 1-[[3-(3,4-Dihydro-5-methyl-4-oxo-7propylimidazo[5,1-f]- as-triazin-2-yl)-4-ethoxyphenyl]sulfony]-4-ethylpiperazine Date of last Update/Change: 02 May 2012

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