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Drug-Drug Interaction Study to Assess the Effects of Multi Dose Clopidogrel on the Pharmacokinetics of Single-Dose K-877 in Healthy Adult Volunteers

NCT ID: NCT02922465

Last Updated: 2016-12-21

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

2016-09-30

Study Completion Date

2016-11-30

Brief Summary

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The primary objective of this study is to assess the effects of clopidogrel on the PK of K-877 in healthy adult subjects.

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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K-877 & Clopidogrel

K-877 \& Clopidogrel orally

Group Type EXPERIMENTAL

K-877

Intervention Type DRUG

Clopidogrel

Intervention Type DRUG

Interventions

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K-877

Intervention Type DRUG

Clopidogrel

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 at screening;
* Subject has a BMI of 18 to 30 kg/m², inclusive;
* Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges, or results that do not show clinically significant abnormalities, as judged by the Investigator at screening and check-in;

Exclusion Criteria

* Subject is a woman who is pregnant or breastfeeding;
* Subject has clinically significant abnormalities in the screening or check-in assessments;
* Subject has current or history of clinically significant coagulation, bleeding, or platelet disorders;
* Subject or a family member of the subject has a history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations, including aneurysms;
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kowa Research Institute, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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K-877-109

Identifier Type: -

Identifier Source: org_study_id