NCT04027192

Study to Test the Safety of Increasing Multiple Doses of BAY2328065 Given by Mouth, How the Drug is Tolerated and Acts in the Human Body of Healthy Male Participants. Alteration of the Study Drug Effects by Another Drug and the Availability of the Drug Given in Different Formulations is Also Tested.

Randomized, Placebo-controlled, Double-blind, Parallel Group Study to Investigate Safety, Tolerability and Pharmacokinetics of Increasing Multiple Oral Doses of BAY2328065 Including the CYP3A4 Induction Potential of BAY2328065 and Randomized Cross-over Investigation of the Relative Bioavailability Between Solution and Tablet Formulation in Healthy Male Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Study on the safety and tolerability of a new drug BAY2328065 when given increased doses as tablet or solution over 12 days to healthy male participants. Researcher want to study how the body absorbs, breaks down and excrete the new drug, also when given together with a test meal. In addition the study will investigate changes that take place in the body when BAY2328065 is given together with another drug.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	BAY2328065 LSF	20 mg/mL LSF (liquid service formulation), orally
DRUG	BAY2328065 tablet	50 mg tablet, orally
DRUG	Placebo LSF	Matching Placebo LSF, orally
DRUG	Placebo tablet	Matching Placebo tablet, orally
DRUG	Midazolam	1 mg per day, orally

Timeline

• Start date: 2019-07-31
• Primary completion: 2020-09-11
• Completion: 2020-11-16
• First posted: 2019-07-19
• Last updated: 2020-11-23

Locations

1 site across 1 country: Germany