Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses of BAY2328065 Including the Relative Bioavailability Between Solution and Tablet Formulation and the Effect of Food on the Pharmacokinetics of BAY2328065 in Healthy Men

19250

This single center, double-blind, randomized study with up to 11 treatment groups evaluates the safety and tolerability, pharmacokinetics, relative bioavailability and food effect of single ascending doses of BAY2328065

2018-03-21

2018-10-29

2019-02-11

Completed

Early phase I

72

Inclusion Criteria: * Healthy male volunteers, aged 18 - 45 years * Body mass index (BMI): 18 ≤ BMI ≤ 30 kg/m² * Smoking less than 10 cigarettes / day * Signed informed consent * Use of an accepted method of contraception for the duration of the study. Exclusion Criteria: * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, thyroid disorders or malignant tumors * Known severe allergies, non allergic drug reactions, or multiple drug allergies * Medication history: any regular medication, esp. drugs known to induce/inhibit liver enzymes or transporters * Clinically relevant findings in physical examination; ECG, blood pressure; laboratory values

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ACTUAL'}}

2024-02-29