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
Overview
- Phase
- Phase 1
- Intervention
- K-877
- Conditions
- Healthy
- Sponsor
- Kowa Research Institute, Inc.
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Cmax of K-877
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
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)
Intervention: K-877
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)
Intervention: K-877
Outcomes
Primary Outcomes
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)
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)
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
- 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)
- 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)
- 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)