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The purpose of this study is to determine the relative bioavailability and pharmacokinetic profiles from three strengths of a new tablet formulation of ASP015K and to evaluate the safety and tolerability after a single dose of three different strengths of a new tablet formulation.
Eligible subjects will be admitted on Day-1 and remain confined on the unit for 16 days. Each subject will receive a single dose of study drug per the defined treatment periods on the mornings of Day 1, Day 6 and Day11. There will be a minimum of 5 days between each consecutive dose group. 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 oral dose low strength |
|
| Treatment B | Experimental | ASP015K oral dose medium strength |
|
| Treatment C | Experimental | ASP015K oral dose high strength |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP015K | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of pharmacokinetic parameters of ASP015K: Cmax, AUClast, and AUCinf | Up to Day 15 |
| 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 15 | |
| 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 Director | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance | Dallas | Texas | 75247 | United States |
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| Up to Day 15 |
| 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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