Drug-Drug Interaction Study to Assess the Effects of Multiple-Dose Administration of K-877 on the Pharmacodynamics and the Pharmacokinetics of Multiple-Dose Administration of Warfarin in Healthy Adult Volunteers

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-02-29

Brief Summary

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The purpose of this study is to assess the effects of K-877 on the pharmacodynamics and the pharmacokinetics of warfarin in healthy adults volunteers.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Warfarin/Warfarin + K-877

Group Type OTHER

Warfarin

Intervention Type DRUG

K-877

Intervention Type DRUG

Interventions

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Warfarin

Intervention Type DRUG

K-877

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject provides written informed consent before any study specific evaluation is performed.
* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive.
* Subject has a body mass index of 18 to 30 kg/m², inclusive.

Exclusion Criteria

* Subject has clinically relevant abnormalities in the screening or check in assessments.
* Subject has clinically significant out-of-range PT, INR, activated partial thromboplastin time, fibrinogen, protein C, or protein S.
* Subject has abnormal prolongation of skin bleeding time at Screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes