Healthy
Conditions
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.
Interventions
DRUGK-877
K-877 Tablet
Sponsors
Kowa Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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) |
Other
| Measure | Time frame |
|---|---|
| Incidence of Treatment-Emergent Adverse Events | Baseline to Day 6 |
Countries
United States
Outcome results
None listed