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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasted-Fed | Experimental | Single dose of K-877 administered in a fasted condition on Day 1 (Treatment Period 1) and postprandially on Day 4 (Treatment Period 2) |
|
| Fed-Fasted | Experimental | Single dose of K-877 administered postprandially on Day 1 (Treatment Period 1) and in a fasted condition on Day 4 (Treatment Period 2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| K-877 | Drug | K-877 Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| MRT0-t of K-877 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Baseline to Day 6 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shona Pendse, MD, MMSc | Kowa Research Institute, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Development, LP | Austin | Texas | 78744 | United States |
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| ID | Term |
|---|---|
| C000603947 | K-877 compound |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |