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This study is designed to evaluate the effect of VX-509 on the pharmacokinetics (PK) of corticosteroids (prednisone or methylprednisolone) and the effect of corticosteroids on the PK of VX-509 and its metabolite. The study will also evaluate the safety and tolerability of VX-509 when coadministered with each of these corticosteroids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Prednisone 10 mg tablet on Day 1 and 7; VX-509 200 mg tablets on Days 2 thru 7 |
|
| Cohort 2 | Experimental | Methylprednisolone 8 mg tablet on Day 1 and 7; VX-509 200 mg tablets on Days 2 thru 7 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug |
| ||
| VX-509 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters including Cmax, area under the concentration-time curve from the time of dosing extrapolated to infinity (AUC0 ∞), and AUC0-last for prednisone and its metabolite prednisolone with or without VX-509 | Multiple blood samples will be obtained over the 10 day open-label treatment phase | |
| PK parameters including Cmax, area under the concentration-time curve from the time of dosing extrapolated to infinity (AUC0 ∞), and AUC0-last for methylprednisolone with or without VX-509 | Multiple blood samples will be obtained over the 10 day open-label treatment phase |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events, results of clinical laboratory tests, vital signs, and 12-lead electrocardiograms | Up to 18 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Vertex Pharmaceuticals Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vertex Investigational Site | Lenexa | Kansas | United States |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| C000596981 | 2-((2-(1H-pyrrolo(2,3-b)pyridin-3-yl)pyrimidin-4-yl)amino)-2-methyl-N-(2,2,2-trifluoroethyl)butanamide |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Methylprednisolone | Drug |
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |