Drug-Drug Interaction Study in Healthy Adult Volunteers
- Registration Number
- NCT02275962
- Lead Sponsor
- Kowa Research Institute, Inc.
- Brief Summary
The purpose of this study is to assess the effects of rifampin on the pharmacokinetics of K-877 in healthy adult volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
- Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
- Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening.
Exclusion Criteria
- Subject has clinically relevant abnormalities in the screening or check in assessments.
- Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females).
- Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description K-877 K-877 K-877 K-877 with Rifampin Rifampin K-877 with Rifampin K-877 with Rifampin K-877 K-877 with Rifampin
- Primary Outcome Measures
Name Time Method Maximum concentration (Cmax) 72 hours
- Secondary Outcome Measures
Name Time Method Area under concentration curve (AUC) 72 hours
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What is the mechanism of rifampin-induced CYP3A4 enzyme induction on K-877 pharmacokinetics in phase 1 trials?
How does K-877 compare to other PPAR agonists in drug-drug interaction profiles for metabolic syndrome management?
Are there specific biomarkers that correlate with K-877 clearance rates when co-administered with rifampin in healthy volunteers?
What are the potential adverse events associated with K-877 and rifampin combination therapy in early-phase clinical trials?
What other pharmaceutical compounds are being studied for PPAR modulation in combination with CYP3A4 inducers like rifampin?
Trial Locations
- Locations (1)
PPD
🇺🇸Austin, Texas, United States
PPD🇺🇸Austin, Texas, United States