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

A Phase 1, Open Label, Fixed-sequence Study to Evaluate the Effect of BAY1841788 (ODM-201) on Drug Transporters Using Rosuvastatin as Probe Substrate and to Assess Pharmacokinetics and Safety of BAY1841788 in Female and Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Evaluation of the potential perpetrator effect of BAY1841788 (ODM-201) on rosuvastatin pharmacokinetics. PK of BAY1841788 (ODM-201) after single and repeated administration in male and female subjects.

Conditions

• Healthy Volunteers
• Pharmacokinetics
• Drug Interaction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-05-01
• Completion: 2016-08-01
• First posted: 2016-02-02
• Last updated: 2016-09-08

Locations

1 site across 1 country: Germany