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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Vertex Investigational Site
Lenexa, Kansas, United States
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
Time frame: 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
Time frame: Multiple blood samples will be obtained over the 10 day open-label treatment phase
Treatment-emergent adverse events, results of clinical laboratory tests, vital signs, and 12-lead electrocardiograms
Time frame: Up to 18 days
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