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| Name | Class |
|---|---|
| Janssen Biotech, Inc. | INDUSTRY |
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The purpose of this study will be to assess the effect of multiple-doses of ASP015K on the pharmacokinetics of rosuvastatin in healthy adult male and female subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP015K + rosuvastatin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASP015K | Drug | oral tablet |
| |
| Rosuvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) parameter for rosuvastatin: AUClast | Area under the curve to the last measurable time | Days 1 and 10 |
| Pharmacokinetic parameter for rosuvastatin: AUCinf | Area under the curve to the infinity | Days 1 and 10 |
| Pharmacokinetic parameter for rosuvastatin: Cmax | Maximum Concentration | Days 1 and 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of pharmacokinetic parameters for rosuvastatin: time after dosing when Cmax occurs (tmax), apparent-terminal elimination half-life (t1/2), apparent volume of distribution (Vz/F), apparent plasma clearance (CL/F) | Days 1 and 10 | |
| Composite of PK parameters for ASP015K: Area under the curve in the dosing interval (AUCtau), Maximum Concentration (Cmax), time after dosing when Cmax occurs (tmax), apparent volume of distribution (Vz/F), apparent plasma clearance at steady (CLss/F) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Global Development, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL - Early Phase Unit | Glendale | California | 91206 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27878567 | Derived | Zhu T, Parker B, Wojtkowski T, Nishimura T, Garg JP, Han D, Fisniku O, Keirns J. Drug Interactions Between Peficitinib, an Orally Administered, Once-Daily Janus Kinase Inhibitor, and Rosuvastatin in Healthy Subjects. Clin Pharmacokinet. 2017 Jul;56(7):747-757. doi: 10.1007/s40262-016-0474-4. |
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| ID | Term |
|---|---|
| C000608065 | peficitinib |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Drug |
oral tablet |
|
| Days 9 and 10 |
| Pharmacokinetic parameter for ASP015K: Ctrough | Plasma concentration immediately before the next administration of study drug | Days 7-10 |
| Pharmacokinetic parameter for ASP015K metabolites: Ctrough | Plasma concentration immediately before the next administration of study drug | Days 7-10 |
| Composite of pharmacokinetic parameters for ASP015K metabolites: Area under the curve in the dosing interval (AUCtau), Maximum Concentration (Cmax), time after dosing when Cmax occurs (tmax) | Days 9 and 10 |
| Safety assessed adverse events, clinical laboratory evaluations, 12-lead ECG measurements, physical examination and vital sign measurements | Day 1-14 |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |