drugset / Trial / NCT03237416

Drug-drug-interaction Study to Assess the Effect of Darolutamide on the Pharmacokinetics of Probe Substrates of CYP3A4 and P-gp in Healthy Male Volunteers

NCT03237416

Phase 1 Completed 15 enrolled Bayer Orion Corporation, Orion Pharma · collab
NaSingle-groupOpen-labelOther

Summary

Evaluate the effect of darolutamide on the pharmacokinetics of a probe CYP3A4 substrate and Pgp substrate

Timeline

Start
2017-08-02
Primary completion
2017-10-05
Completion
2017-12-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabigatran etexilate Unknown 75 mg
Subject Darolutamide Other / unclassified 600 mg
Subject Midazolam Small molecule 1 mg

Indications