Drug-drug Interaction (DDI) Study to Assess ODM-201 as a Victim of CYP3A4 Inhibition or Induction

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

February 15, 2017

Primary Completion Date

May 4, 2017

Study Completion Date

July 19, 2017

Conditions
Biological Availability
Interventions
DRUG

BAY1841788 (ODM-201)

In Period 1, 600 mg single dose administered as 2x300 mg tablets on Study Day 1, In Period 2, 600 mg single dose administered as 2x300 mg tablets on Study Day 5, In Period 3, 600 mg single dose administered as 2x300 mg tablets at Study Day 8.

DRUG

Itraconazole

200 mg twice daily (BID) administered as 2 x 100 mg capsules per dose in treatment period 2 on Study Day 1, 200 mg once daily (QD) administered as 2 x 100 mg capsules per dose in treatment period 2 on Study Days 2 to 7.

DRUG

Rifampicin

600 mg QD administered as 1 x 600 mg tablet per dose in treatment period 3 on Study Days 1 to 10.

Trial Locations (1)

13353

CRS Clinical Research Services Berlin GmbH, Berlin

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Orion Corporation, Orion Pharma

INDUSTRY

lead

Bayer

INDUSTRY