Dexpramipexole and Warfarin Drug Drug Interaction (DDI) Study

Knopp Biosciences

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Warfarin

Drug: Dexpramipexole

Study type

Interventional

Funder types

Industry

Identifiers

NCT01597310

223HV105

Details and patient eligibility

About

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

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects who, in the opinion of the investigator, are healthy as determined by medical history, physical examination, and 12 Lead ECG.
Adult males/females aged 18 to 55 years inclusive.
Male and female subjects of childbearing age must practice effective contraception during the study and up to 90 days after their last dose of study drug.

Exclusion criteria

History of malignant disease, including solid tumors and hematologic malignancies.
Clinically significant current active infection or serious infection.
History of gastrointestinal bleeding, peptic ulcer disease, hemorrhoids or epistaxis.
Personal or family history of any bleeding disorder, and/or coagulation profile results outside of normal limits.
Known allergy or hypersensitivity to warfarin.