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

Completed · Phase 1

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT02922465

Run by

Kowa Research Institute, Inc.

People needed

20

Starts

2016-09-01

Expected to finish

2016-11-01

Last updated by the study team

2016-12-21

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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;

Where it is running

• Study site — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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