Pharmacokinetic Drug-Drug Interaction Study Between K-877 and CSG452 in Healthy Adult Volunteers
- Registration Number
- NCT04237597
- Lead Sponsor
- Kowa Research Institute, Inc.
- Brief Summary
A study to compare the pharmacokinetic(s) of K-877 and CSG452 when each drug is administered alone and when both are administered together.
- 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, at Screening.
- Subject has a BMI of 18 to 30 kg/m2, inclusive, at Screening.
- Subject meets all other inclusion criteria outlined in the clinical study protocol
Exclusion Criteria
- Subject has clinically relevant abnormalities at Screening or at Check-in assessments.
- Subject is pregnant or breastfeeding or intends to become pregnant within 30 days after the last dose of study drug.
- Subject does not meet any other exclusion criteria outlined in the clinical study protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description K-877 & CSG452 K-877 K-877 Single dose on Day 1 and Day 15 CSG452 Repeat dose on Day 2 Through Day 15 K-877 & CSG452 CSG452 K-877 Single dose on Day 1 and Day 15 CSG452 Repeat dose on Day 2 Through Day 15
- Primary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) 0 to 24 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PPD Development. LP
🇺🇸Austin, Texas, United States