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

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

August 2, 2017

Primary Completion Date

October 5, 2017

Study Completion Date

December 18, 2017

Conditions
Prostatic Neoplasms
Interventions
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

Trial Locations (1)

68167

CRS Clinical-Research-Services Mannheim GmbH, Mannheim

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Orion Corporation, Orion Pharma

INDUSTRY

lead

Bayer

INDUSTRY