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 Overview
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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.

Official Title
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A Randomized, Open-Label, Six-Sequence, Three-Period Crossover Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER Plus CSG452 in Healthy Adult Volunteers, and to Characterize the Food Effect on the Pharmacokinetics of K-001

Conditions
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Healthy

Intervention / Treatment
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* Drug: K-001
* Drug: K-877-ER
* Drug: CSG452


Participation Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Randomized, open-label, six-sequence, three-period, crossover study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>Three period alternative intervention and fed/fasted sequence | Drug: K-001<br>* K-877-ER and CSG452 combination tablet<br>Drug: K-877-ER<br>* K-877-ER tablet<br>Drug: CSG452<br>* CSG452 tablet<br>|
| Experimental: Sequence B<br>Three period alternative intervention and fed/fasted sequence | Drug: K-001<br>* K-877-ER and CSG452 combination tablet<br>Drug: K-877-ER<br>* K-877-ER tablet<br>Drug: CSG452<br>* CSG452 tablet<br>|
| Experimental: Sequence C<br>Three period alternative intervention and fed/fasted sequence | Drug: K-001<br>* K-877-ER and CSG452 combination tablet<br>Drug: K-877-ER<br>* K-877-ER tablet<br>Drug: CSG452<br>* CSG452 tablet<br>|
| Experimental: Sequence D<br>Three period alternative intervention and fed/fasted sequence | Drug: K-001<br>* K-877-ER and CSG452 combination tablet<br>Drug: K-877-ER<br>* K-877-ER tablet<br>Drug: CSG452<br>* CSG452 tablet<br>|
| Experimental: Sequence E<br>Three period alternative intervention and fed/fasted sequence | Drug: K-001<br>* K-877-ER and CSG452 combination tablet<br>Drug: K-877-ER<br>* K-877-ER tablet<br>Drug: CSG452<br>* CSG452 tablet<br>|
| Experimental: Sequence F<br>Three period alternative intervention and fed/fasted sequence | Drug: K-001<br>* K-877-ER and CSG452 combination tablet<br>Drug: K-877-ER<br>* K-877-ER tablet<br>Drug: CSG452<br>* CSG452 tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of K-877 and CSG452 | Maximum observed plasma concentration (Cmax) of K-877 and CSG452 | 1 hour before dosing and at multiple time points (up to 48 hours) post dose | 
| AUC0-t of K-877 and CSG452 | Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) | 1 hour before dosing and at multiple time points (up to 48 hours) post dose | 
| AUC0-inf of K-877-and CSG452 | Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf). | 1 hour before dosing and at multiple time points (up to 48 hours) post dose |