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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: K-877; Drug: Clopidogrel

• Registration Number: NCT02922465
• Lead Sponsor: Kowa Research Institute, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-15
• Study First Submitted QC: 2016-09-30
• Primary Completion: 2016-10
• Study First Posted: 2016-10-04
• Study Completion: 2016-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2016-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
K-877 & Clopidogrel	K-877	K-877 \& Clopidogrel orally
K-877 & Clopidogrel	Clopidogrel	K-877 \& Clopidogrel orally

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.