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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-24

Study Completion Date

2023-04-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Randomized, open-label, six-sequence, three-period, crossover study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sequence A

Three period alternative intervention and fed/fasted sequence

Group Type EXPERIMENTAL

K-001

Intervention Type DRUG

K-877-ER and CSG452 combination tablet

K-877-ER

Intervention Type DRUG

K-877-ER tablet

CSG452

Intervention Type DRUG

CSG452 tablet

Sequence B

Three period alternative intervention and fed/fasted sequence

Group Type EXPERIMENTAL

K-001

Intervention Type DRUG

K-877-ER and CSG452 combination tablet

K-877-ER

Intervention Type DRUG

K-877-ER tablet

CSG452

Intervention Type DRUG

CSG452 tablet

Sequence C

Three period alternative intervention and fed/fasted sequence

Group Type EXPERIMENTAL

K-001

Intervention Type DRUG

K-877-ER and CSG452 combination tablet

K-877-ER

Intervention Type DRUG

K-877-ER tablet

CSG452

Intervention Type DRUG

CSG452 tablet

Sequence D

Three period alternative intervention and fed/fasted sequence

Group Type EXPERIMENTAL

K-001

Intervention Type DRUG

K-877-ER and CSG452 combination tablet

K-877-ER

Intervention Type DRUG

K-877-ER tablet

CSG452

Intervention Type DRUG

CSG452 tablet

Sequence E

Three period alternative intervention and fed/fasted sequence

Group Type EXPERIMENTAL

K-001

Intervention Type DRUG

K-877-ER and CSG452 combination tablet

K-877-ER

Intervention Type DRUG

K-877-ER tablet

CSG452

Intervention Type DRUG

CSG452 tablet

Sequence F

Three period alternative intervention and fed/fasted sequence

Group Type EXPERIMENTAL

K-001

Intervention Type DRUG

K-877-ER and CSG452 combination tablet

K-877-ER

Intervention Type DRUG

K-877-ER tablet

CSG452

Intervention Type DRUG

CSG452 tablet

Interventions

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K-001

K-877-ER and CSG452 combination tablet

Intervention Type DRUG

K-877-ER

K-877-ER tablet

Intervention Type DRUG

CSG452

CSG452 tablet

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes