A Phase 1, First-in-human Study of VX-634
- Registration Number
- NCT05579431
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VX-634 at various doses.
- Detailed Description
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.).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
- Participants of age between 18 to 55 years (inclusive)
- 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
- Participants of non childbearing potential
- Non smoker or ex-smoker for at least 3 months before screening
Key
- Any condition possibly affecting drug absorption
Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A VX-634 Participants grouped in different cohorts will receive a single ascending dose of VX-634. Placebo Part A Placebo Participants will be randomized to receive placebo matched to VX-634. Placebo Part B Placebo Participants will be randomized to receive placebo matched to VX-634. Part B VX-634 Participants grouped in different cohorts will receive multiple doses of VX-634.The dose levels will be determined based on the data from Part A.
- Primary Outcome Measures
Name Time Method Part A and B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Day 1 up to Day 20
- Secondary Outcome Measures
Name Time Method Part A and B: Urine Concentration of VX-634 Part A Cohort A3: Days 1 and 5; Part B Cohort B3: Days 1, 10 and 11 Part A and B: Maximum Observed Plasma Concentration (Cmax) of VX-634 Day 1 up to Day 20 Part A and B: Area Under the Concentration Versus Time Curve (AUC) of VX-634 Day 1 up to Day 20
Trial Locations
- Locations (5)
Central Florida Pulmonary Group, P.A.
🇺🇸Orlando, Florida, United States
ICON Lenexa
🇺🇸Lenexa, Kansas, United States
ICON Salt Lake City
🇺🇸Salt Lake City, Utah, United States
Celerion - Tempe
🇺🇸Tempe, Arizona, United States
University of Florida
🇺🇸Gainesville, Florida, United States