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

Kowa

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: K-877

Study type: Interventional

Funder types: Industry

Identifiers

NCT04742218

K-877-110

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Fasted-Fed

Experimental group

Description:

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

Treatment:

Drug: K-877

Fed-Fasted

Experimental group

Description:

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

Treatment:

Drug: K-877