Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Janssen Biotech, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the relative bioavailability of ASP015K under fasting conditions after single-dose administration between a test-tablet formulation and a reference-tablet formulation. This study will also evaluate the food effect on bioavailability of the test formulation, and evaluate the safety and tolerability after single-dose administration of the test- and reference-tablet formulations.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP015K Test Tablet - Fasting Conditions | Experimental | ASP015K administered as a single tablet under fasting conditions. |
|
| ASP015K Reference Tablet - Fasting Conditions | Experimental | ASP015K administered via multiple tablets under fasting conditions |
|
| ASP015K Test Tablet -Fed Conditions | Experimental | ASP015K administered as a single tablet under fed conditions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP015K | Drug | oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter of ASP015K: Cmax | Maximum Concentration (Cmax) | Day 1-4 of each treatment period |
| Pharmacokinetic parameter of ASP015K: AUClast | Area Under the Curve from time zero to the last measurable time (AUClast) | Day 1-4 of each treatment period |
| Pharmacokinetic parameter of ASP015K: AUCinf | Area Under the Curve from time zero extrapolated to infinity (AUCinf) | Day 1-4 of each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of pharmacokinetic parameters of ASP015K: tmax, t1/2 | Time to Maximum Concentration (tmax), apparent terminal elimination half-life (t1/2) | Day 1-4 of each treatment period |
| Composite of pharmacokinetic parameters of ASP015K metabolites: Cmax, AUClast, AUCinf, tmax, t1/2 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel - Early Phase Clinical Unit | Baltimore | Maryland | 21225 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Day 1-4 of each treatment period |
| Safety assessed by adverse events, clinical laboratory evaluations, 12-lead ECG measurements, physical examinations and vital sign measurements | Up to Day 4 in each treatment period |
| ID | Term |
|---|---|
| C000608065 | peficitinib |
Not provided
Not provided
Not provided