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

Kowa

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CSG452; Drug: K-001; Drug: K-877-ER

Study type: Interventional

Funder types: Industry

Identifiers

NCT05722262

K-001-1.02

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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30 participants in 6 patient groups

Sequence A

Experimental group

Description:

Three period alternative intervention and fed/fasted sequence

Treatment:

Drug: K-001

Drug: CSG452

Drug: K-877-ER

Sequence B

Experimental group

Description:

Three period alternative intervention and fed/fasted sequence

Treatment:

Drug: K-001

Drug: CSG452

Drug: K-877-ER

Sequence C

Experimental group

Description:

Three period alternative intervention and fed/fasted sequence

Treatment:

Drug: K-001

Drug: CSG452

Drug: K-877-ER

Sequence D

Experimental group

Description:

Three period alternative intervention and fed/fasted sequence

Treatment:

Drug: K-001

Drug: CSG452

Drug: K-877-ER

Sequence E

Experimental group

Description:

Three period alternative intervention and fed/fasted sequence

Treatment:

Drug: K-001

Drug: CSG452

Drug: K-877-ER

Sequence F

Experimental group

Description:

Three period alternative intervention and fed/fasted sequence

Treatment:

Drug: K-001

Drug: CSG452

Drug: K-877-ER