Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VX-272, Placebo.
- Who it may be relevant to
- Registry conditions: Cystic Fibrosis. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-272 in Healthy Subjects
Overview
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of VX-272.
Detailed description
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.)
Interventions
- Drug VX-272
Suspension for Oral Administration. - Drug Placebo
Suspension for Oral Administration.
Primary outcome measures
- Part 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]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
- A total body weight of more than (>) 50 kg
- Male and Female participants of non-childbearing potential
Exclusion criteria
- History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
- Any condition possibly affecting drug absorption
Other protocol defined Inclusion/Exclusion criteria may apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Celerion - Tempe — Tempe
Identifiers
NCT: NCT07437105 · VX25-272-001