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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: K-877

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Development, LP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: K-877; K-877 Tablet
Experimental: 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)	Drug: K-877; K-877 Tablet

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Incidence of Treatment-Emergent Adverse Events	Baseline to Day 6

Collaborators and Investigators

• Sponsor: Kowa Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2021
• Primary Completion (Actual): April 11, 2021
• Study Completion (Actual): April 11, 2021

Study Registration Dates

• First Submitted: January 29, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: K-877-110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No