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The objective of the study is to characterize the effect of multiple doses of ASP015K on the pharmacokinetics of a single oral dose or a single intravenous (IV) dose of tacrolimus.
This is a 2-part study. Part 1 is a 2-sequence, drug interaction study to determine the effect of two different ASP015K doses on the pharmacokinetics of oral tacrolimus. Part 2 is a 1-sequence drug interaction study to determine the effect of the higher dose ASP015K on the pharmacokinetics of IV tacrolimus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1, Group 1 | Experimental | ASP015K, low dose followed by high dose, with oral tacrolimus |
|
| Part 1, Group 2 | Experimental | ASP015K, high dose followed by low dose, with oral tacrolimus |
|
| Part 2 | Experimental | ASP015K high dose with intravenous tacrolimus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus | Drug | Oral and Intravenous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables assessment through analysis of blood and urine samples | Days 1-13 and Days 26-33 (Part 1 only) sampled daily |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Global Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Honolulu | Hawaii | 96813 | United States |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| C000608065 | peficitinib |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| ASP015K | Drug | Oral |
|