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

Kowa

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: K-877

Drug: Clopidogrel

Study type

Interventional

Funder types

Industry

Identifiers

K-877-109

Details and patient eligibility

About

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

Enrollment

20 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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;