Drug-drug Interaction Study Using Rosuvastatin as a Breast Cancer Resistant Protein (Efflux Transporter), Organic Anion-transporting Polypeptide (OATP)1B1, and OATP1B3 (Uptake Transporters) Probe Substrate

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

May 31, 2016

Study Completion Date

August 31, 2016

Conditions
Healthy VolunteersPharmacokineticsDrug Interaction
Interventions
DRUG

Rosuvastatin

5 mg tablet single dose on Day 01 in Period 1 and on Day 08 in Period 2.

DRUG

BAY1841788 (ODM-201)

600 mg single dose, administered as 2 x 300 mg tablets on Day 01 in Period 2; 600 mg BID multiple dose, administered as 2 x 300 mg tablets on Day 04 to Day 08 in Period 2.

Trial Locations (1)

13353

CRS Clinical Research Services Berlin GmbH, Berlin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT02671097 - Drug-drug Interaction Study Using Rosuvastatin as a Breast Cancer Resistant Protein (Efflux Transporter), Organic Anion-transporting Polypeptide (OATP)1B1, and OATP1B3 (Uptake Transporters) Probe Substrate | Biotech Hunter | Biotech Hunter