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Dexpramipexole and Warfarin Drug Drug Interaction (DDI) Study

NCT ID: NCT01597310

Last Updated: 2014-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2012-07-31

Brief Summary

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

Detailed Description

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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

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Warfarin

25 mg Warfarin, Treatment Period 1 \& Treatment Period 2

Group Type EXPERIMENTAL

Warfarin

Intervention Type DRUG

single doses at specified time periods

Dexpramipexole

150 mg BID Treatment Period 2

Group Type EXPERIMENTAL

Dexpramipexole

Intervention Type DRUG

multiple doses

Interventions

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Warfarin

single doses at specified time periods

Intervention Type DRUG

Dexpramipexole

multiple doses

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Knopp Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Overland Park, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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223HV105

Identifier Type: -

Identifier Source: org_study_id