drugset / Trial / 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.

NCT04027192 ↗

Phase 1 Completed 50 enrolled Bayer
RandomizedParallel-groupQuadruple-blindBasic science

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.

Timeline

Start
2019-07-31
Primary completion
2020-09-11
Completion
2020-11-16

Drugs

EvaluationDrugModalityDoseRoute
Subject BAY2328065 Unknown 50 mg Oral
Subject Midazolam Small molecule 1 mg Oral

Indications