Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER and CSG452
- Registration Number
- NCT05722262
- Lead Sponsor
- Kowa Research Institute, Inc.
- Brief Summary
The goal of this clinical trial is to demonstrate the bioequivalence of single oral administration of K-001 relative to single oral co-administration of separate tablets of K-877-ER and CSG452 in healthy adult volunteers, and to characterize the food effect on the Pharmacokinetics(PK) of K-001.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Participant provides written informed consent before any study-specific evaluation is performed.
- Participant is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
- Participant has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
- Participant meet all other inclusion criteria outlined in the clinical study protocol.
Exclusion Criteria
- Participant has clinically significant abnormalities at Screening or at Check-in assessments, in the opinion of the investigator.
- Participant is pregnant or breastfeeding or intends to become pregnant within 30 days after the last dose of study drug.
- Participant meets any other exclusion criteria outlined in the clinical study protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Sequence A K-001 Three period alternative intervention and fed/fasted sequence Sequence A K-877-ER Three period alternative intervention and fed/fasted sequence Sequence A CSG452 Three period alternative intervention and fed/fasted sequence Sequence B K-877-ER Three period alternative intervention and fed/fasted sequence Sequence B CSG452 Three period alternative intervention and fed/fasted sequence Sequence C K-877-ER Three period alternative intervention and fed/fasted sequence Sequence C CSG452 Three period alternative intervention and fed/fasted sequence Sequence D K-001 Three period alternative intervention and fed/fasted sequence Sequence D K-877-ER Three period alternative intervention and fed/fasted sequence Sequence D CSG452 Three period alternative intervention and fed/fasted sequence Sequence E K-001 Three period alternative intervention and fed/fasted sequence Sequence E K-877-ER Three period alternative intervention and fed/fasted sequence Sequence E CSG452 Three period alternative intervention and fed/fasted sequence Sequence F K-001 Three period alternative intervention and fed/fasted sequence Sequence F K-877-ER Three period alternative intervention and fed/fasted sequence Sequence B K-001 Three period alternative intervention and fed/fasted sequence Sequence C K-001 Three period alternative intervention and fed/fasted sequence Sequence F CSG452 Three period alternative intervention and fed/fasted sequence
- Primary Outcome Measures
Name Time Method Cmax of K-877 and CSG452 1 hour before dosing and at multiple time points (up to 48 hours) post dose Maximum observed plasma concentration (Cmax) of K-877 and CSG452
AUC0-t of K-877 and CSG452 1 hour before dosing and at multiple time points (up to 48 hours) post dose Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)
AUC0-inf of K-877-and CSG452 1 hour before dosing and at multiple time points (up to 48 hours) post dose Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PPD - Austin Research Unit
🇺🇸Austin, Texas, United States