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 labelling 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 Test Product Study Sponsor: Clinical Trial Results Synopsis Bayer HealthCare AG Study Design Description Study Number: EudraCT number: Study Phase: I Official Study Title: A randomized, open-label, single center, crossover study to compare the pharmacokinetics of iloprost following inhalation of Ventavis 10 or Ventavis 20 solution with the I-Neb nebulizing device in healthy male volunteers under the condition of an extended inhalation time Therapeutic Area: Cardiology/Coagulation Name of Test Product: Name of Active Ingredient: Dose and Mode of Administration: Reference Therapy/Placebo Iloprost (Ventavis, BAYQ 6256) Iloprost Reference Therapy: None Dose and Mode of Administration: Treatment A: A single dose of 5 μg iloprost in aerosol generated by the I-Neb nebulizer using Ventavis 10 solution (containing 10 μg/ml iloprost). Treatment B: A single dose of 5 μg iloprost in aerosol generated by the I-Neb nebulizer using Ventavis 20 solution (containing 20 μg/ml iloprost). Route of administration: Inhalation Duration of Treatment: Single-dose inhalations with an extended inhalation time. Studied period: Date of first subject s first visit: 03 MAY 2012 Date of last subject s last visit: 22 JUN 2012 Premature Study Suspension / Termination: Substantial Study Protocol Amendments: No None Study Centre(s): This study was conducted at a single center in Germany. Methodology: This single-center, open-label, crossover study comprised 5 periods: screening, pre-dose, 2 treatment periods (each of approximately 8 hours long including one single-dose inhalation of the study medication (Treatment A or Treatment B)), and follow-up. The screening period started with the subject's informed consent and continued until the start of the pre-dose period, which contained a final check of the inclusion/exclusion criteria and the investigator's decision as to whether the subject was eligible for treatment. Subjects were trained to inhale with an extended inhalation time defined as >15 min when using Ventavis 10. The treatment periods started with the baseline measurements and lasted until either the start of the next treatment period or until the follow-up period. During the treatment Page 1 of 5

3 Indication/ Main Inclusion Criteria: periods, pharmacokinetic (PK) sampling and a check of pulse rate and blood pressure were performed for approximately 6 hours after the end of dosing. Between the treatment periods, a wash-out phase of at least 24 hours was ensured. The follow-up examination was performed within one week after the last PK sample had been taken. Pharmacokinetic analysis was done using liquid chromatographytandem mass spectrometry. Indication: Primary pulmonary hypertension Study Objectives: Evaluation Criteria: Main inclusion criteria: Healthy male volunteers aged years (non- or ex-smokers; with no clinically relevant spirometric findings) were included in the study. Overall: The primary objective of this study was to compare the pharmacokinetics of iloprost following inhalation of the 10 μg/ml iloprost formulation (Ventavis 10) with the pharmcokinetics of iloprost following inhalation of the 20 μg/ml iloprost formulation (Ventavis 20), using the I-Neb nebulizing system in subjects with an extended inhalation time. In addition, acute safety and tolerability following Ventavis administration of both the formulations were monitored. Efficacy: Safety: Adverse events, laboratory values, vital signs Pharmacokinetics: The primary (i.e., PK) analysis was conducted with the following variables: Area under the plasma concentration time curve of iloprost (AUC). If AUC could not be determined reliably in all subjects according to acceptance criteria of the Bayer guidelines, then AUC(0-tlast) was to be used instead. Statistical Methods: Efficacy: Secondary PK parameters: t1/2, AUC(0 tlast), if not primary, Cmax, tmax, tlast. Safety: Individual listings of AEs were prepared, and treatment-emergent and drug-related AEs were summarized by treatment using MedDRA terms. Hematological and clinico-chemical data, vital signs, and ECG were described by summary statistics. Graphical displays of individual and mean data and tables of abnormal values were presented. Pharmacokinetics: Plasma concentration time courses of iloprost after inhalation were Page 2 of 5

4 tabulated by treatment. For each sampling point, arithmetic mean, standard deviation, and coefficient of variation (CV); geometric mean, geometric standard deviation, and CV; minimum, median, maximum value, and the number of measurements were calculated. Individual and geometric mean concentration time curves were plotted. Pharmacokinetic characteristics were summarized. Number of Subjects: The primary statistical analysis consisted in comparing the PK of Ventavis 10 solution with those of Ventavis 20 solution: logarithms of area under the curve and maximum concentration were compared by analysis of variance, including sequence, subject (sequence), period, and treatment effects. Point estimates (least-squares means) and exploratory 90% confidence intervals for the treatment ratio were calculated by re-transformation of the logarithmic data. Planned: 20 subjects Analyzed: 21 subjects included in safety evaluation; 19 subjects included in PK analysis Results Summary Subject Disposition and Baseline Study Results A total of 44 men were screened and, of these, 20 either failed to meet the criteria for study participation (13 subjects) or withdrew their consent to participate (7 subjects), while 3 others were excluded for logistical reasons. Thus, 20 were initially randomized to one of the two treatment sequences and received the study treatment; further, a subject was later added to replace one who was withdrawn before completing treatment. Thus, 21 subjects were eligible for safety analysis; valid PK data were obtained from 19 subjects. Demographic and baseline data were comparable for the two treatment-sequence groups. The mean age ± SD of the 21 subjects included in the safety analysis was 36.5 ± 7.4 years (range: years), and the mean body mass index was 25.7 ± 2.4 kg/m 2 (range: kg/m 2 ). All the subjects were Caucasian. Of the 21 men, 11 subjects (52%) had never smoked, and the other 10 subjects (48%) had smoked previously but were no longer smoking at the time the study was conducted. Three subjects (14%) stated at the time of the screening visit that they did not drink alcohol, while 17 subjects (81%) stated that they were "light" drinkers and one subject (5%) stated that he was a "moderate" drinker. Results Summary Efficacy Results Summary Safety Adverse events were recorded for two subjects (10%) after administration of Ventavis 10 and for ten subjects (48%) after administration of Ventavis 20. The most frequent event was flushing [in 2 subjects (10%) and 7 subjects (33%) with Ventavis 10 and Ventavis 20, respectively].other AEs recorded were blood creatinine increased, gamma-glutamyltransferase increased, headache, presyncope, and spontaneous penile erection; these AEs were recorded, for one subject each, with Ventavis 20 only. All events, except one (headache), were considered related to the study drug; all were rated as "mild" except for presyncope (in one subject), which was rated as "moderate" and led to the subject's withdrawal from the study. Laboratory values and measurements of vital signs did not reveal any general differences between the two treatments. Results Summary Pharmacokinetics Table 1 summarizes the PK parameters of Ventavis 10 and Ventavis 20 as geometric means, geometric standard deviation, and coefficient of variation, except for tlast and tmax where the Page 3 of 5

5 median value together with minimum and maximum value is presented. Table 1: Mean pharmacokinetic parameters of Ventavis 10 and Ventavis 20 in plasma after inhalation of 5 µg iloprost Very similar systemic exposures were observed between the two treatments, which fits with the equal doses of 5 μg iloprost inhaled in the two treatment periods (using either Ventavis 10 or Ventavis 20). As anticipated, following inhalation by healthy male subjects of 5 μg iloprost as a 10 μg/l concentrated solution (Ventavis 10) or 20 μg/l concentrated solution (Ventavis 20), an approximately 30% reduction in mean inhalation time was observed after inhalation of Ventavis 20. The shorter inhalation time with Ventavis 20 is consistent with the lower inhalation volume of Ventavis 20 (0.25 ml, compared with 0.5 ml for Ventavis 10). An approximately 30% higher mean maximum concentration was measured following inhalation of 5 μg Ventavis 20 compared with 5 μg Ventavis 10, which is consistent with the observed shorter mean inhalation time. Iloprost was eliminated from plasma with similar terminal half-lives after inhalation of Ventavis 10 and Ventavis 20. Conclusion(s) In this open-label crossover study, either a 10 μg/l iloprost solution (Ventavis 10) or a 20 μg/l iloprost solution (Ventavis 20) was used for inhalation of 5 μg iloprost by healthy subjects under the specific conditions of extended inhalation times. Similar systemic exposures were observed following treatment with Ventavis 10 or Ventavis 20, which is in accord with the equal doses of 5 μg iloprost inhaled during both treatments. As anticipated, an approximately 30% reduction of the mean inhalation time was reported Page 4 of 5

6 after inhalation of Ventavis 20. Consistent with the observed shorter inhalation time, an approximately 30% higher mean maximum serum concentration was found following inhalation of Ventavis 20 compared with Ventavis 10. No serious AEs, or any AEs with a severe intensity, occurred in this study. The side effect profile, with flush as the most frequent AE, is in line with the known safety profile of Ventavis. One AE (presyncope following treatment with Ventavis 20) led to withdrawal of treatment. The observed iloprost exposure in this subject, however, does not provide a reasonable explanation for this finding. In comparison with the known side-effect profile and considering the transient nature of the AEs, no special safety concerns were deduced from this study for Ventavis 10 or Ventavis 20. Publication(s): Date Created or Date Last Updated: None 09 JUL 2013 Date of Clinical Study Report: 17 APR 2013 Page 5 of 5

7 Investigational Site List Marketing Authorization Holder in Germany Name Bayer Vital GmbH Postal Address D Leverkusen Germany Sponsor in Germany (if applicable) Legal Entity Name Postal Address Bayer Pharma AG D Leverkusen Germany List of Investigational Sites No Investigator Name Facility Name 1 Hr. Dr. M Berse Bayer Pharma AG Street Global Drug Discovery Clinical Pharmacology Sellerstr. 31 ZIP Code City Country Berlin Germany Page 1 of 1

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