This trial is active, not recruiting.

Condition healthy
Treatments k-877, clopidogrel
Phase phase 1
Sponsor Kowa Research Institute, Inc.
Start date September 2016
End date October 2016
Trial size 20 participants
Trial identifier NCT02922465, K-877-109


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics study
Intervention model single group assignment
Masking open label
K-877 & Clopidogrel orally

Primary Outcomes

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

Secondary Outcomes

Evaluation of 20 participants with treatment emergent adverse events as assessed by the principle investigator
time frame: Through study completion up to 17 days.

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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;

Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Kowa Research Institute, Inc..