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

A Phase I, Non-randomized, Open-label, Fixed-sequence Study to Investigate the Effect of Darolutamide (ODM-201) on the Pharmacokinetics of a Probe Substrate of CYP3A4 and P-gp in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	Dabigatran etexilate	In Period 1, Day 1 a single dose of 75 mg will be administered after breakfast In Period 2, Day 3 a single dose of 75 mg will be administered prior to breakfast In Period 2, Day 9 a single dose of 75 mg will be administered after breakfast
DRUG	Midazolam	In Period 1, Day 1 a single dose of 1 mg will be administered after breakfast In Period 2, Day 9 a single dose of 1 mg will be administered after breakfast
DRUG	BAY1841788 (darolutamide)	In Period 2, Days 1-11 600 mg twice a day (as 2 x 300 mg tablets) will be administered after breakfast

Timeline

• Start date: 2017-08-02
• Primary completion: 2017-10-05
• Completion: 2017-12-18
• First posted: 2017-08-02
• Last updated: 2018-11-06

Locations

1 site across 1 country: Germany