NCT02169440

Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin

Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Bial - Portela C S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate CYP2C9 inhibition by BIA 9-1067 through the assessment of its effect on the pharmacokinetics of S-warfarin, a substrate of CYP2C9.

Detailed description

Single-centre, open-label, randomised, two-way crossover study in healthy young male and female volunteers. The study was to consist of 2 treatment periods separated by a washout period of 14 days or more. In one period, subjects were to receive a single-dose of 25 mg BIA 9-1067 with a single-dose of racemic 25 mg warfarin. In the other period, a 25 mg warfarin single-dose was to be administered alone.

Conditions

• Parkinson's Disease (PD)

Interventions

Type	Name	Description
DRUG	BIA 9-1067	BIA 9-1067 25 mg
DRUG	Warfarin	Warfarin 25 mg

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2014-06-23
• Last updated: 2015-12-22
• Results posted: 2015-12-22

Locations

1 site across 1 country: Portugal