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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021160-15 | EudraCT Number |
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The objective of the study is to assess the bioavailability of ASP015K within the gastrointestinal tract.
Each subject will participate in four separate study periods. In each period, subjects will be admitted to the clinical unit approximately seven hours on the day prior to being given study drug. Subjects will remain at the clinical research unit for the next 24 hours after they have received study drug. Subjects will return to the clinical research unit at 36 and 48 hours after they have received study drug to give blood samples. There will be a minimum of a four day "washout" period, between each study period.
Under certain circumstances, subjects may be asked to return to the clinical research unit for an additional study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A | Experimental | ASP015K oral tablet |
|
| Regimen B | Experimental | ASP015K solution delivered to distal small bowel via oral capsule |
|
| Regimen C | Experimental | ASP015K solution delivered to ascending colon via oral capsule |
|
| Regimen D | Experimental | ASP015K solution delivered to distal transverse colon via oral capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP015K | Drug | oral tablet |
| |
| ASP015K |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic assessment of AUC through the analysis of blood samples | Up to 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic assessment of maximum concentration (Cmax) through the analysis of blood samples | Up to 45 days |
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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 |
|---|---|---|---|---|---|---|
| Quotient Clinical Limited | Ruddington | Nottingham | NG116JS | United Kingdom |
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| ID | Term |
|---|---|
| C000608065 | peficitinib |
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| Drug |
solution via oral capsule |
|