Dexpramipexole and Warfarin Drug Drug Interaction (DDI) Study

November 24, 2014 updated by: Knopp Biosciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Warfarin
25 mg Warfarin, Treatment Period 1 & Treatment Period 2
Drug: Warfarin
single doses at specified time periods
EXPERIMENTAL: Dexpramipexole
150 mg BID Treatment Period 2
Drug: Dexpramipexole
multiple doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determination of the effect of dexpramipexole on the pharmacokinetics (PK) parameters of the CYP2C9 probe substrate warfarin including: AUC: area under the plasma-concentration time curve over a specified time period and Cmax: Maximum observed plasma c
Time Frame: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hours after warfarin administration in each dosing period
pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hours after warfarin administration in each dosing period
PK parameters of dexpramipexole including but not limited to AUC: area under the plasma-concentration time curve over a specified time period and Cmax: Maximum observed plasma concentration
Time Frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after administration of the morning dexpramipexole dose on Day 1 and Day 12 of Period 2
pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after administration of the morning dexpramipexole dose on Day 1 and Day 12 of Period 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Knopp Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

May 10, 2012

First Submitted That Met QC Criteria

May 10, 2012

First Posted (ESTIMATE)

May 14, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 25, 2014

Last Update Submitted That Met QC Criteria

November 24, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 223HV105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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