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The objective of this study is to explore safety and tolerability of multiple oral doses of ASP015K in healthy volunteers.
Subjects will be confined to the clinical research unit for 19 days. Subjects will receive a follow-up phone call to asses safety 1 to 5 days after being discharged from the study.
Subjects will receive study drug twice per day (BID) on days 1 to 13 of the 14 day treatment period, and will receive a single dose of study drug on the morning of day 14 of the treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | low dose, all male |
|
| Group B | Experimental | medium dose, all male |
|
| Group C | Experimental | high dose, all male |
|
| Group D | Experimental | medium dose, all female |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP015K | Drug | oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability assessed through vital signs, electrocardiograms (ECGs), physical exams, reports of adverse events, and analysis of blood and urine samples | 25 days | |
| Pharmacokinetic assessment through the analysis of blood and urine samples | 17 days | |
| Pharmacodynamic assessment through the analysis of blood samples | 17 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 |
|---|---|---|---|---|---|---|
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | United States |
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| ID | Term |
|---|---|
| C000608065 | peficitinib |
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| Placebo |
| Drug |
oral |
|