The purpose of this study is to evaluate the safety, tolerability, and PK of single and multiple ascending doses of VX-840 in healthy participants.
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
88
ICON Lenexa
Lenexa, Kansas, United States
Parts A and 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 25
Parts A and B: Plasma Concentration of VX-840 Over Time
Time frame: From Day 1 up to Day 14
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity [AUC(0 - inf)]
Time frame: From Day 1 up to Day 14
Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration [AUC(0-tlast)]
Time frame: From Day 1 up to Day 14
Part B: Amount of VX-840 Excreted in the Urine During the Dosing Interval (Ae)
Time frame: From Day 1 up to Day 14
Part B: Associated Renal Clearance (CLr) of VX-840
Time frame: From Day 1 up to Day 14
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