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
- Registration Number
- NCT02719431
- Lead Sponsor
- Kowa Research Institute, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Warfarin/Warfarin + K-877 K-877 - Warfarin/Warfarin + K-877 Warfarin -
- Primary Outcome Measures
Name Time Method International normalized ratio (INR) 22 Days
- Secondary Outcome Measures
Name Time Method