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 Clinical Trial Results Synopsis Study Design Description Study Sponsor: Bayer HealthCare AG Test Product Study Number: Study Phase: I Official Study Title: Single dose escalation study to investigate safety, tolerability and pharmacokinetics of increasing inhalative doses of Acetylsalicylic Acid (BAY ) in a randomized, single-blind, group-comparison design in healthy male subjects Therapeutic Area: Analgesics and Anti-inflammatory Name of Test Product: Name of Active Ingredient: Dose and Mode of Administration: D,L-lysine acetylsalicylate glycine (Aspirin [for inhalation], BAY ) D,L-lysine acetylsalicylate glycine Dose (Nebulized aqueous solution): Starting dose was equivalent to 62.5 mg acetylsalicylic acid (ASA), corresponding to 125 mg BAY ; further doses were 125 mg ASA, 250 mg ASA, 500 mg ASA, 750 mg ASA. Route of adminitration: Inhalative Reference Therapy/Placebo Reference Therapy: Inactive; NaCl 0.9% aqueous solution Dose and Mode of Administration: Dose: Volume equivalent to BAY solution dose Route of adminitration: Inhalative Duration of Treatment: Inhalation of single nebulized BAY solution doses, and inhalation of a single NaCl 0.9% solution dose. Studied period: Date of first subjects first visit: 13 JUL 2010 Date of last subjects last visit: 14 DEC 2010 Premature Study Suspension / Termination: Substantial Study Protocol Amendments: No None Study Centre(s): The study was conducted at a single site in Germany. Page 1 of 6

3 Methodology: The total duration of the study was approximately 20 weeks including replacement of subjects. The dose increase was decided based on results for safety and pharmacokinetics of the previous dose steps. Due to the high absorption of study drug, no increase of dose beyond 750 mg ASA was conducted (maximal single dose was in the range of 1000 mg ASA). Pharmacokinetics (PK): Plasma concentrations and PK parameters of acetylsalicylic acid and salicylic acid were assessed. Blood sampling for PK was carried out prior to and up to 2 days after inhalation. Urine sampling for PK was done prior to and continuously up to 2 days after inhalation. Safety evaluation: Occurrence of treatment-emergent adverse events, incidence of abnormal findings: vital parameters, ECG (electrocardiogram) findings, laboratory findings, lung function testing were peformed. Indication/ Main Inclusion Criteria: Analysis of biomarker was done. Blood sampling for Thromboxane2 was done at various time-points starting 1 day prior to inhalation and up to 2 days after inhalation. Blood sampling for platelet aggregation (optional at higher dose steps) was done prior to and up to 3 hours after inhalation. Indication: Influenza treatment Study Objectives: Main Inclusion Criteria: Healthy male subjects, aged years Primary: To investigate the safety and tolerability of BAY solution administered as a single oral inhalation in young healthy male subjects. Evaluation Criteria: Secondary: To investigate the pharmacokinetics of acetylsalicylic acid and its metabolite salicylic acid after single-dose inhalations of nebulized aqueous BAY solution in healthy male subjects. Efficacy (Primary): Not applicable Efficacy (Secondary): Not applicable Safety: Primary safety and tolerability parameters for BAY : Adverse events, blood pressure, heart rate, ECG parameters, lung function parameters, clinical laboratory, and hematology. Page 2 of 6

4 Pharmacokinetics: Primary PK parameters for ASA and SA: AUC, AUC/D, Cmax, Cmax/D Secondary PK parameters for ASA and SA: AUCnorm, AUC(0-tn), AUC(tn- ), Cmax,norm, tmax, t1/2, CL/F, Vz/F. Other PK parameters for ASA and SA: Aeur (mg,%), CLR Other: Biomarkers Statistical Methods: Efficacy (Primary): Not applicable Efficacy (Secondary): Not applicable Safety: Summary statistics (arithmetic mean, standard deviation, median, minimum and maximum for quantitative variables) were presented by treatment group. Frequency tables for qualitative data were provided. Medical history findings were summarized using MedDRA (Medical Dictionary for Regulatory Activities) terms. Pharmacokinetics: To investigate dose-proportionality an explorative Analysis of variance i.e., ANOVA (including the factor treatment) were performed on the log-transformed values of the dose-normalized pharmacokinetic parameters. Number of Subjects: Analyzed: 38 subjects (5 subjects in the treatment group 62.5 mg ASA, 5 in group 125 mg, 6 in group 250 mg, 6 in group 500 mg, and 6 in group 750 mg ASA, 10 on inactive treatment). Study Results Results Summary Subject Disposition and Baseline Fifty-five (55) subjects entered the trial. Of these, 39 subjects were randomized at the center. Thirty-eight (38) subjects received treatment, and one subject dropped out because he withdrew consent. Thus, 38 subjects with mean age of 34.2 years (range: 18.0 to 45.0 years), and mean BMI of 24.4 kg/m 2 (range: 19.8 to 29.5 kg/m 2 ) were treated. All subjects were White. Results Summary Safety In total, treatment-emergent AEs occurred in 23 of 38 subjects (60%). The most frequently occurring treatment-emergent AEs were: throat irritation (14 subjects: 1 subject in the treatment group 125 mg ASA, 3 in group 250 mg, 5 in group 500 mg, and 5 in group 750 mg ASA), productive cough (3 subjects: 1 subject in the treatment group 125 mg ASA, and 2 in group 750 mg ASA), and vessel puncture site reaction (3 subjects: 1 subject in the treatment group 500 mg ASA, and 2 in the NaCl 0.9% group). The maximum intensity of most AEs was "mild"; AEs in 2 subjects were assessed as "moderate". For none of the AEs, the maximum intensity "severe" was documented. All Page 3 of 6

5 treatment emergent AEs were "resolved/recovered" at the end of the study. Fifteen (15) subjects experienced treatment-emergent AEs, which were assessed as being related to the study drug: 2 subjects in the treatment group 125 mg ASA, 3 in group 250 mg, 5 in group 500 mg, and 5 in group 750 mg ASA. The drug-related treatment-emergent AEs were throat irritation in 14 subjects (36% of the subjects) and productive cough in 3 subjects (7% of the subjects). In summary, treatment-emergent AEs were seen more often in subjects who received higher drug doses than in the lower dose treatment groups and placebo. Although a higher rate of throat irritation occurred at higher doses, no effect on PFT (Pulmonary function test) parameter was seen. Vital signs such as heart rate, systolic/diastolic blood pressure, and mean arterial pressure and ECG parameters were not affected by the study drug administration. Regarding lung function, no changes of the values (FEV1 (Forced expiratory volume in 1 second) related to inspiratory VC (vital capacity), FEV1, FVC (Forced Vital Capacity), maximal vital capacity) were observed between measurements prior to and after study drug inhalation. For the examination of spirometry, no relevant decrease (>5%) of the mean values of FEV1 related to inspiratory VC from start of inhalation to measurements afterwards could be observed in any treatment group. In summary, the lung function was not affected by drug inhalation in comparison to NaCl solution. Results Summary Pharmacokinetics Clinical pharmacology evaluation: BAY was administered in order to investigate the pharmacokinetics of ASA and its metabolite SA (salicylic acid) after single-dose inhalations of nebulized aqueous BAY solution in healthy male subjects. The following two tables (Table 1 and Table 2) summarize the results as geometric means, geometric coefficients of variation (% CV [coefficient of variation]), and ranges of the pharmacokinetic parameters for ASA and SA by treatment. Page 4 of 6

6 Table 1: Pharmacokinetic parameters of Acetylsalicylic Acid in plasma following a single inhalative dose of Aspirin Inhale (geometric mean/% CV (range), PK analysis set) Table 2: Pharmacokinetic parameters of Salicylic Acid in plasma following a single inhalative dose of Aspirin Inhale (geometric mean/% CV (range), PK analysis set) Results Summary Other Biomarker: Thromboxane2 (TXB2): TXB2 serum concentrations at start of inhalation reflected high inter-individual variability prior to treatment. Mean pre-treatment values of the 6 treatment groups and the inactive group were between 237 and 556 μg/l. ASA inhalation caused a rapid and nearly complete inhibition of TXB2 in serum reflecting the fast absorption of ASA, i.e., mean TXB2 serum concentrations decreased by 64 to 97% of the baseline value 10 min after ASA inhalation. This was significantly different from inactive treatment where values did not change. Page 5 of 6

7 TXB2 serum concentrations remained low in ASA treatment groups until 24 hours after inhalation, thereafter, a slight increase of the concentration values was observed. A maximum inhibition was reached at about 20 minutes after end of inhalation. There were no major differences between the effects of 125 mg, 250 mg, 500 mg, and 750 mg ASA while analyzed values for the lowest dosing group 62.5 mg were lower. Biomarker: Platelet aggregation Systemic action of ASA led to complete inhibition of platelet aggregation with all doses tested (250 mg, 500 mg, 750 mg). Conclusion(s) In this study, BAY administered as a single oral inhalation to 38 healthy male subjects was safe and well tolerated. Inhalative treatments with nebulized BAY solution led to a rapid absorption of ASA via the bronchopulmonary system and the lung. When comparing ASA inhalation doses ranging from 62.5 to 750 mg, dose proportionality for ASA was demonstrated for AUC/D and Cmax/D. After ASA inhalation doses of 62.5 to 750 mg, the systemic action of ASA led to fast and significant reduction of TXB2 serum concentrations (64 to 97% of baseline value 10 min after ASA inhalation). Systemic action of ASA led to complete inhibition of platelet aggregation with all doses tested (250 mg, 500 mg, 750 mg). Publication(s): Date Created or Date Last Updated: None 18 MAY 2012 Date of Clinical Study Report: 21 DEC 2011 Page 6 of 6

8 Marketing Authorization Holder in Germany Appendix to Clinical Study Synopsis for study Investigational Site List Name Bayer Vital GmbH Postal Address D Leverkusen, Germany Sponsor in Germany Legal Entity Name Bayer HealthCare AG Postal Address D Leverkusen, Germany List of Investigational Sites No Investigator Name Facility Name Street ZIP Code City Country 1 J Nagelschmitz Bayer HealthCare AG, Research Center, Clinical Pharmacology Bayer HealthCare / Bayer Pharma AG Global Drug Discovery / Clinical Pharmacology Pharmacodynamics Geb Wuppertal Germany Page 1 of 1

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