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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: K-001; Drug: K-877-ER; Drug: 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

Study Timeline

• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-10
• Study Start: 2023-02-24
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-05
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-01
• Last Update Posted: 2023-06-02

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.

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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.

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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-001	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-001	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 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).

Trial Locations

Locations (1)

PPD - Austin Research Unit; 🇺🇸 Austin, Texas, United States