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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 45
Updated:12/22/2016
Start Date:September 2016
End Date:November 2016

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


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;
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