A Phase 1, First-in-human Study of Safety, Tolerability, and Pharmacokinetics of VX-634
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 127
- Locations
- 5
- Primary Endpoint
- Part A and B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Study Overview
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.).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •Any condition possibly affecting drug absorption
- •Other protocol defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
Part A
Participants grouped in different cohorts will receive a single ascending dose of VX-634.
Intervention: VX-634 (Drug)
Placebo Part A
Participants will be randomized to receive placebo matched to VX-634.
Intervention: Placebo (Drug)
Part B
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.
Intervention: VX-634 (Drug)
Placebo Part B
Participants will be randomized to receive placebo matched to VX-634.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Part A and B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1 up to Day 20
Secondary Outcomes
- 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)