The purpose of the study is to evaluate the relative bioavailability (BA) and the effect of food on the pharmacokinetics (PK), and the safety and tolerability of VX-147 test tablet formulation.
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Tablets for oral administration.
ICON Salt Lake City
Salt Lake City, Utah, United States
Maximum Observed Plasma Concentration (Cmax) of VX-147 Test Compared to VX-147 Reference
Time frame: From Day 1 up to Day 16
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-147 Test Compared to VX-147 Reference
Time frame: From Day 1 up to Day 16
Cmax of VX-147 Test Compared Under Fed Versus Fasted State
Time frame: From Day 1 up to Day 16
AUC(0-inf) of VX-147 Test Compared Under Fed Versus Fasted State
Time frame: From Day 1 up to Day 16
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious AEs
Time frame: From Day -1 up to Day 27
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