CompletedInterventionalPhase 1Updated Oct 27, 2014
Drug-Drug Interaction Study to Assess the Effects of Multiple-Dose Administration of K-877 on the Pharmacodynamics and the Pharmacokinetics of... | NCT02719431 | Trialant
CompletedInterventionalPhase 1Updated Mar 25, 2016
Drug-Drug Interaction Study to Assess the Effects of Multiple-Dose Administration of K-877 on the Pharmacodynamics and the Pharmacokinetics of Multiple-Dose Administration of Warfarin in Healthy Adult Volunteers
ClinicalTrials.gov ID
NCT02719431
Lead Sponsor
Kowa Research Institute, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
20Actual
Last Update Posted
Mar 25, 2016Estimated
Start Date
Jan 2016
Primary Completion Date
Feb 2016Actual
Completion Date
Feb 2016Actual
Brief Summary
The purpose of this study is to assess the effects of K-877 on the pharmacodynamics and the pharmacokinetics of warfarin in healthy adults volunteers.
Healthy
Warfarin
K-877
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.
Subject has a body mass index of 18 to 30 kg/m², inclusive.
Exclusion Criteria:
Subject has clinically relevant abnormalities in the screening or check in assessments.
Subject has clinically significant out-of-range PT, INR, activated partial thromboplastin time, fibrinogen, protein C, or protein S.
Subject has abnormal prolongation of skin bleeding time at Screening.