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The objective of the study is to explore safety and tolerability of single ascending doses of ASP015K, establish the maximum tolerated dose, and determine the pharmacokinetics and pharmacodynamics in healthy volunteers.
Subjects will be confined to the clinical research unit for five days. Some subjects will participate in two confinement periods. Subjects will receive a follow-up phone call to assess safety seven days after the administration of the single dose of study drug.
Subjects will be assigned to one of nine sequential groups A, B, C, D, E, F, G, H, or I. In each group, 6 subjects will be randomized to ASP015K and 2 subjects will be randomized to placebo. Subjects in group F will participate in two treatment periods. Subjects in the first treatment period of group F will have a single study drug dose administered in the fasted state. Subjects in the second treatment period of group F will have a single study drug dose administered immediately following a standard FDA recommended high-fat breakfast.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Lowest dose, all males, fasting |
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| Group B | Experimental | Second lowest dose, all males, fasting |
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| Group C | Experimental | Third lowest dose, all males, fasting |
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| Group D | Experimental | Middle dose, all males, fasting |
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| Group E | Experimental | Third lowest dose, all females, fasting |
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| Group F | Experimental | Third highest dose, all males, fasting then fed |
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| Group G |
| 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 | 8 days | |
| Pharmacokinetic assessment through the analysis of blood and urine samples | Up to Day 4 | |
| Pharmacodynamic assessment through the analysis of blood samples | Up to Day 4 |
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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 |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami | Miami | Florida | 33014 | United States | ||
| Prism Research |
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| ID | Term |
|---|---|
| C000608065 | peficitinib |
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| Experimental |
Second highest dose, all males, fasting |
|
| Group H | Experimental | Highest dose, all males, fasting |
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| Group I | Experimental | Second highest dose, all females, fasting |
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| Placebo Group A | Placebo Comparator | all male, fasting |
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| Placebo Group B | Placebo Comparator | all male, fasting then fed |
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| Placebo Group C | Placebo Comparator | all female, fasting |
|
| Placebo | Drug | oral |
|
| Saint Paul |
| Minnesota |
| 55114 |
| United States |