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

Sponsor

Kowa Research Institute, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02922465

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: K-877 Drug: Clopidogrel	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: K-877 & Clopidogrel K-877 & Clopidogrel orally	Drug: K-877 Drug: Clopidogrel

Arm

Intervention/Treatment

Experimental: K-877 & Clopidogrel

K-877 & Clopidogrel orally

Drug: K-877

Drug: Clopidogrel

Outcome Measures

Primary Outcome Measures

Plasma exposure of K-877 by measuring Cmax when administered alone or with Clopidogrel [Up to 72 hours after dosing]
Plasma exposure of K-877 by measuring AUC when administered alone or with Clopidogrel [Up to 72 hours after dosing]

Secondary Outcome Measures

Evaluation of 20 participants with treatment emergent adverse events as assessed by the principle investigator [Through study completion up to 17 days.]
Subjects will be questioned in a general way by the investigator without specific symptoms suggested.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Cincinnati	Ohio	United States	45227

Sponsors and Collaborators

Kowa Research Institute, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kowa Research Institute, Inc.

ClinicalTrials.gov Identifier:

NCT02922465

Other Study ID Numbers:

K-877-109

First Posted:

Oct 4, 2016

Last Update Posted:

Dec 21, 2016

Last Verified:

Dec 1, 2016

Additional relevant MeSH terms:

Clopidogrel

Study Results

No Results Posted as of Dec 21, 2016