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

NCT04742218 | Completed Phase 1 FDA Drug

• 1 other identifier: K-877-110
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

• 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

• 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

• 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

• 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

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Baseline to Day 6

Study Arms (2)

Fasted-Fed

EXPERIMENTAL

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

Fed-Fasted

EXPERIMENTAL

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

Interventions

K-877 DRUG

K-877 Tablet

Fasted-Fed; Fed-Fasted

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kowa Research Institute, Inc.: lead

Study Sites (1)

PPD Development, LP

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

K-877 compound

Study Officials

• Shona Pendse, MD, MMSc

  Kowa Research Institute, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 8, 2021
• Study Start: January 13, 2021
• Primary Completion: April 11, 2021
• Study Completion: April 11, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)