NCT03048110

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

A Phase I, Non-randomized, Open-label, Fixed-sequence Study to Investigate the Effect of a Probe CYP3A4 Inhibitor and Inducer on the Pharmacokinetics of BAY1841788 (ODM 201) 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 a probe CYP3A4 inhibitor and inducer on the pharmacokinetics of BAY1841788 (ODM-201)

Conditions

• Biological Availability

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-02-15
• Primary completion: 2017-05-04
• Completion: 2017-07-19
• First posted: 2017-02-09
• Last updated: 2018-07-30

Locations

1 site across 1 country: Germany