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 evaluate the effect of verapamil, a P-glycoprotein (P-gp) inhibitor, on the pharmacokinetics of ASP015K. This study will also assess the safety and tolerability of ASP015K administered alone and also and in combination with verapamil.
Eligible subjects will be admitted to the clinical unit on day -1 and remain confined until day 15.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP015K and verapamil | Experimental | Single dose of ASP015K, then repeat dose of verapamil, then a second single dose of ASP015K while continuing verapamil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP015K | Drug | oral |
| |
| verapamil |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of ASP015K: Maximum concentration (Cmax) | Days 1-4 and Days 12-15 | |
| Pharmacokinetics of ASP015K: Area under the concentration-time curve (AUC) from time of dosing to the last quantifiable concentration (AUClast) | Days 1-4 and Days 12-15 | |
| Pharmacokinetics of ASP015K: AUC from the time of dosing extrapolated to time infinity (AUCinf) | Days 1-4 and Days 12-15 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile of ASP015K: time of maximum plasma concentration (tmax), terminal elimination half-life (t½), apparent total systemic clearance (CL/F), and apparent volume of distribution during the terminal elimination phase (Vz/F) | Days 1-4 and Days 12-15 | |
| Pharmacokinetic profile of ASP015K metabolites: Cmax, AUClast, AUCinf, tmax and t½ |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Pharmacology Lead | Astellas Pharma Global Development, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL | Glendale | California | 91206 | United States |
Not provided
| ID | Term |
|---|---|
| C000608065 | peficitinib |
| D014700 | Verapamil |
| ID | Term |
|---|---|
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
oral |
|
|
| Days 1-4 and Days 12-15 |