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Study to evaluate the safety and tolerability of single ascending doses and multiple ascending doses of VX-509 administered to healthy male and female subjects
Part A of the study will evaluate the safety and tolerability, PK, and PD of single ascending doses of VX-509.
Part B will evaluate the safety and tolerability, PK, and PD of multiple ascending doses of VX-509 administered for 14 days.
A total of 72 subjects will be enrolled: 36 subjects in Part A and 36 subjects in Part B.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VX-509 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability as measured by adverse events (AEs) and clinically relevant changes in laboratory values, vital signs, electrocardiograms (ECGs), and physical examination variables | Specified timepoints in the protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) parameters (Cmax, AUC, t1/2, tmax) | Specified timepoints in the protocol | |
| Pharmacodynamics (PD)parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers | Specified timepoints in the protocol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Spencer-Green, MD, MS | Vertex Pharmaceuticals Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lenexa | Kansas | United States |
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| ID | Term |
|---|---|
| C000596981 | 2-((2-(1H-pyrrolo(2,3-b)pyridin-3-yl)pyrimidin-4-yl)amino)-2-methyl-N-(2,2,2-trifluoroethyl)butanamide |
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