A Phase 1, First-in-human Study of Safety, Tolerability, and Pharmacokinetics of VX-634
Status: Completed
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VX-634 at various doses.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:
• 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
Locations
United States
Arizona
Celerion - Tempe
Tempe
Florida
University of Florida
Gainesville
Central Florida Pulmonary Group, P.A.
Orlando
Kansas
ICON Lenexa
Lenexa
Utah
ICON Salt Lake City
Salt Lake City
Time Frame
Start Date: 2022-10-13
Completion Date: 2023-11-13
Participants
Target number of participants: 127
Treatments
Experimental: Part A
Participants grouped in different cohorts will receive a single ascending dose of VX-634.
Placebo_comparator: Placebo Part A
Participants will be randomized to receive placebo matched to VX-634.
Experimental: 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.
Placebo_comparator: Placebo Part B
Participants will be randomized to receive placebo matched to VX-634.
Related Therapeutic Areas
Sponsors
Leads: Vertex Pharmaceuticals Incorporated