NCT01597310

Dexpramipexole and Warfarin Drug Drug Interaction (DDI) Study

An Open-Label Study to Assess the Effect of Dexpramipexole (BIIB050) on the Pharmacokinetics of Warfarin in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Knopp Biosciences · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will assess the effect of dexpramipexole on the pharmacokinetics (PK) of the CYP2C9 probe substrate warfarin in healthy volunteers.

Detailed description

This is a single center open label study to assess the effect of Dexpramipexole on the PK of Warfarin in Healthy Volunteers. The goals of this study are as follows: to assess the effect of dexpramipexole on the pharmacodynamics (PD) of warfarin, to assess the safety and tolerability of dexpramipexole when administered alone, and with warfarin, and to assess the PK of dexpramipexole when administered alone; to explore the influence of genetic variation on the PK and international normalized ratio (INR) of warfarin when administered alone, and with dexpramipexole; and to explore the influence of genetic variation on the PK of dexpramipexole when administered alone.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Warfarin	single doses at specified time periods
DRUG	Dexpramipexole	multiple doses

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-05-14
• Last updated: 2014-11-25

Locations

1 site across 1 country: United States