Study to Assess the Food Effect of K-877 in Healthy Adult Volunteers
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
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
- 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)
- 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)
- 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
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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
- Incidence of Treatment-Emergent Adverse Events [Baseline to Day 6]
Eligibility Criteria
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:
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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.- K-877-110