drugset / Trial / NCT02894385

Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201)

NCT02894385

Phase 1 Completed 29 enrolled Bayer Orion Corporation, Orion Pharma · collab
Non-randomizedParallel-groupOpen-labelOther

Summary

Evaluate the potential effect of hepatic or renal impairment on the pharmacokinetics, safety and tolerability of BAY 1841788 (ODM-201).

Timeline

Start
2016-09-13
Primary completion
2017-04-10
Completion
2017-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Darolutamide Other / unclassified 600 mg Oral