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

Sponsor
Kowa Research Institute, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04742218
Collaborator
(none)
18
1
2
2.9
6.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
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
Actual Study Start Date :
Jan 13, 2021
Actual Primary Completion Date :
Apr 11, 2021
Actual Study Completion Date :
Apr 11, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Cmax 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]

    Observed maximum plasma concentration (Cmax)

  2. AUC0-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]

    Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)

  3. AUC0-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]

    Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf)

Secondary Outcome Measures

  1. 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]

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

  2. 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]

    Mean residence time from time 0 to the time of the last quantifiable concentration (MRT0-t)

  3. 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]

    Mean residence time from time 0 extrapolated to infinity (MRT0-inf)

  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]

    Terminal elimination half-life (t1/2)

  5. 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]

    Terminal elimination rate constant (Kel)

  6. CL/F 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]

    Apparent oral clearance (CL/F)

  7. Vd/F 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]

    Apparent volume of distribution (Vd/F)

Other Outcome Measures

  1. Incidence of Treatment-Emergent Adverse Events [Baseline to Day 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 PPD Development, LP Austin Texas United States 78744

Sponsors and Collaborators

  • Kowa Research Institute, Inc.

Investigators

  • Study Chair: Shona Pendse, MD, MMSc, Kowa Research Institute, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT04742218
Other Study ID Numbers:
  • K-877-110
First Posted:
Feb 8, 2021
Last Update Posted:
Aug 9, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 9, 2021