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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04742218
• Other study ID #: K-877-110
• Status: Completed
• Phase: Phase 1
• Start date: January 13, 2021
• Est. completion date: April 11, 2021

Study information

• Verified date: August 2021
• Source: Kowa Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 11, 2021
• Est. primary completion date: April 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• K-877
K-877 Tablet

Locations

Country	Name	City	State
United States	PPD Development, LP	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Kowa Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Treatment-Emergent Adverse Events		Baseline to Day 6
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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