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

Phase 1CompletedNCT04742218

Kowa Research Institute, Inc.18 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

18

Conditions

Interventions

K-877 Tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

PPD Development, LP

Austin, Texas, United States

Outcomes

Primary Outcomes

Cmax of K-877

Observed maximum plasma concentration (Cmax)

Time frame: 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)

Time frame: 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)

Time frame: 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 Outcomes

Tmax of K-877

Time to reach the observed maximum (peak) plasma concentration (Tmax)

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

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NCT04742218 - Study to Assess the Food Effect of K-877 in Healthy Adult Volunteers | Crick | Crick