CompletedInterventionalPhase 1Updated Aug 30, 2010
Drug-Drug Interaction Study to Assess the Effects of Multi Dose Clopidogrel on the Pharmacokinetics of Single-Dose K-877 in Healthy Adult Volunteers | NCT02922465 | Trialant
CompletedInterventionalPhase 1Updated Dec 21, 2016
Drug-Drug Interaction Study to Assess the Effects of Multi Dose Clopidogrel on the Pharmacokinetics of Single-Dose K-877 in Healthy Adult Volunteers
ClinicalTrials.gov ID
NCT02922465
Lead Sponsor
Kowa Research Institute, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
20Actual
Last Update Posted
Dec 21, 2016Estimated
Start Date
Sep 2016
Primary Completion Date
Oct 2016Actual
Completion Date
Nov 2016Actual
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.
Healthy
K-877
Clopidogrel
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
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;