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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: K-877

• Registration Number: NCT04742218
• Lead Sponsor: Kowa Research Institute, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-13
• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-02-02
• Study First Posted: 2021-02-08
• Primary Completion: 2021-04-11
• Study Completion: 2021-04-11
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fasted-Fed	K-877	Single dose of K-877 administered in a fasted condition on Day 1 (Treatment Period 1) and postprandially on Day 4 (Treatment Period 2)
Fed-Fasted	K-877	Single dose of K-877 administered postprandially on Day 1 (Treatment Period 1) and in a fasted condition on Day 4 (Treatment Period 2)

Primary Outcome Measures

Name	Time	Method
Cmax of K-877	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	Observed maximum plasma concentration (Cmax)
AUC0-t of K-877	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	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	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	Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf)

Secondary Outcome Measures

Name	Time	Method
Tmax of K-877	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	Time to reach the observed maximum (peak) plasma concentration (Tmax)
MRT0-t of K-877	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	Mean residence time from time 0 to the time of the last quantifiable concentration (MRT0-t)
MRT0-inf of K-877	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	Mean residence time from time 0 extrapolated to infinity (MRT0-inf)
t1/2 of K-877	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	Terminal elimination half-life (t1/2)
Kel of K-877	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	Terminal elimination rate constant (Kel)
CL/F of K-877	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	Apparent oral clearance (CL/F)
Vd/F of K-877	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	Apparent volume of distribution (Vd/F)

Trial Locations

Locations (1)

PPD Development, LP; 🇺🇸 Austin, Texas, United States