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Completed

NCT Number: NCT04742218

Study to Assess the Food Effect 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.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Development, LP

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

K-877

Drug

K-877 Tablet

Primary outcomes

  1. Cmax of K-877

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Tmax of K-877

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: Baseline to Day 6

Sponsors and collaborators

Lead sponsor

Kowa Research Institute, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2021
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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