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The purpose of this study is to determine the bioavailability and pharmacokinetics between two different formulations of ASP015K tablets and determine the food effect on the absorption of the new formulation.
Eligible subjects will be admitted on Day -2 and remain confined on the unit for 20 days. Each subject will receive a single dose of study drug per the defined treatment periods on the morning of Day 1, Day 8 and Day 15. There will be a minimum of 7 days between each consecutive dose group.
For Treatment A, Formulation 1 tablets will be administered within 30 minutes after the start of a standard FDA moderate-fat breakfast. Treatment B, Formulation 2 tablets will be administered in a fasted state. For Treatment C, Formulation 2 tablets will be administered within 30 minutes after the start of a standard FDA moderate-fat breakfast.
Any subject discontinuing the study prior to completion should have all end of study evaluations completed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | ASP015K Formulation 1 with moderate-fat meal |
|
| Treatment B | Experimental | ASP015K Formulation 2 under fasting conditions |
|
| Treatment C | Experimental | ASP015K Formulation 2 with moderate-fat meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP015K | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of pharmacokinetic parameters of ASP015K: C max, AUClast, and AUCinf | Up to Day 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of pharmacokinetic parameters of ASP015K: tmax, apparent terminal elimination half-life (t1/2), apparent body clearance after oral dosing (CL/F), and apparent volume of distribution (Vz/F) | Up to Day 18 | |
| Composite of pharmacokinetic parameters of ASP015K metabolite H2: Cmax, AUClast, AUCinf, tmax and t1/2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL | Glendale | California | 91206 | United States |
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| Up to Day 18 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C000608065 | peficitinib |
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