The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of VX-272.
The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of VX-272 in healthy participants. Note: 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
QUADRUPLE
Enrollment
128
Celerion - Tempe
Tempe, Arizona, United States
RECRUITINGPart A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day -1 up to Day 34
Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day -1 up to Day 66
Part A: Maximum Observed Plasma Concentration (Cmax) of VX-272
Time frame: From Day 1 up to Day 34
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of VX-272
Time frame: From Day 1 up to Day 34
Part B: Maximum Observed Plasma Concentration (Cmax) of VX-272
Time frame: From Day 1 up to Day 66
Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of VX-272
Time frame: From Day 1 up to Day 66
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