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

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-13

Study Completion Date

2021-04-11

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.

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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

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Fasted-Fed

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

Group Type EXPERIMENTAL

K-877

Intervention Type DRUG

K-877 Tablet

Fed-Fasted

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

Group Type EXPERIMENTAL

K-877

Intervention Type DRUG

K-877 Tablet

Interventions

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K-877

K-877 Tablet

Intervention Type DRUG

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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes