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The purpose of this study is to compare the pharmacokinetics (PK) profiles of three different strengths of ASP015K extended release formulation and an immediate release formulation and to evaluate food effect on extended release strengths in healthy volunteers.
Study involves 3 parallel groups. Subjects in each group will receive 3 single-dose treatments with a washout period of at least 7 days separating the dosing between two consecutive treatments. Dosing conditions include both fed and fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Group 1 Treatment A | Experimental | Lowest per tablet dose of ASP015K Extended Release (ER) tablets under fasted conditions |
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| Dose Group 1 Treatment B | Active Comparator | Medium per tablet dose ASP015K Immediate Release (IR) tablets under fasted conditions for comparison to lowest dose ER fasted conditions |
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| Dose Group 1 Treatment C | Experimental | Lowest per tablet dose of ASP015K ER tablets under fed conditions |
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| Dose Group 2 Treatment D | Experimental | Medium per tablet dose of ASP015K ER tablets under fasted conditions |
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| Dose Group 2 Treatment E | Active Comparator | Medium per tablet dose of ASP015K IR tablets under fasted conditions for comparison to medium dose ER fasted conditions |
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| Dose Group 2 Treatment F |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP015K ER | Drug | oral extended release (ER) at three dosing levels |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) for ASP015K (in plasma): Area under the curve (AUC) from time 0 extrapolated to infinity (AUCinf) | Day 1-4 of each of 3 dosing periods | |
| PK for ASP015K (in plasma): AUC from time of dosing to last quantifiable concentration (AUClast) | Days 1-4 of each of 3 dosing periods | |
| PK for ASP015K (in plasma): Maximum concentration (Cmax) | Days 1-4 of each of 3 dosing periods |
| Measure | Description | Time Frame |
|---|---|---|
| PK profile for ASP015K (in plasma): tmax , t1/2 , Vz /F, and CL/F | Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2 ), apparent volume of distribution (Vz /F), apparent body clearance after oral dosing (CL/F) | Day 1-4 of each of 3 dosing periods |
| PK profile for metabolites (in plasma): Cmax, AUClast, and AUCinf, tmax,t1/2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International | Baltimore | Maryland | 21225 | United States |
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Medium per tablet dose of ASP015K ER tablets under fed conditions |
|
| Dose Group 3 Treatment G | Experimental | Highest per tablet dose of ASP015K ER tablets under fasted conditions |
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| Dose Group 3 Treatment H | Active Comparator | Medium per tablet dose of ASP015K IR tablets under fasted conditions for comparison to highest dose ER under fasted conditions |
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| Dose Group 3 Treatment I | Experimental | Highest dose of ASP015K ER tablets under fed conditions |
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| ASP015K IR | Drug | oral immediate release (IR) |
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| Day 1-4 of each of 3 dosing periods |