Study to Assess the Food Effect of K-877 in Healthy Adult Volunteers

Study Overview
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Brief Summary
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Study is to assess the effects of food on the Pharmacokinetics(PK) of single-dose administration of K-877 in healthy adult volunteers.

Official Title
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A Randomized, Open Label, Two-sequence, Two-period Crossover Study to Assess the Food Effect on the Pharmacokinetics of Single-Dose Administration of the To-Be-Marketed Formulation of K-877 in Healthy Adult Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: K-877


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject provides written informed consent before any study-specific evaluation is performed; Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at screening; Subject has a BMI of 18 to 30 kg/m2, inclusive, at screening Subject meets all inclusion criteria outlined in the clinical study protocol Exclusion Criteria: Subject is a woman who is pregnant or breastfeeding; Subject has clinically significant abnormalities in the screening or check-in assessments; Subject has received an investigational drug within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug Subject does not meet any other exclusion criteria outlined in 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasted-Fed<br>Single dose of K-877 administered in a fasted condition on Day 1 (Treatment Period 1) and postprandially on Day 4 (Treatment Period 2) | Drug: K-877<br>* K-877 Tablet<br>|
| Experimental: Fed-Fasted<br>Single dose of K-877 administered postprandially on Day 1 (Treatment Period 1) and in a fasted condition on Day 4 (Treatment Period 2) | Drug: K-877<br>* K-877 Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax of K-877 | Observed maximum plasma concentration (Cmax) | pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4 | 
| AUC0-t of K-877 | Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) | pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4 | 
| AUC0-inf of K-877 | Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf) | pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax of K-877 | Time to reach the observed maximum (peak) plasma concentration (Tmax) | pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4 | 
| MRT0-t of K-877 | Mean residence time from time 0 to the time of the last quantifiable concentration (MRT0-t) | pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4 | 
| MRT0-inf of K-877 | Mean residence time from time 0 extrapolated to infinity (MRT0-inf) | pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4 | 
| t1/2 of K-877 | Terminal elimination half-life (t1/2) | pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4 | 
| Kel of K-877 | Terminal elimination rate constant (Kel) | pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4 | 
| CL/F of K-877 | Apparent oral clearance (CL/F) | pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4 | 
| Vd/F of K-877 | Apparent volume of distribution (Vd/F) | pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4 |