BAY2328065 Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Relative Bioavailability, Food Effect

• Status: Completed
• Trial end date: 2019-02-11
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer

Criteria

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