A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Extension Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of VX-407 in Healthy Subjects
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of VX-407 in healthy participants.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:
• Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
• A total body weight of greater than (\>) 50 kg
• Nonsmoker or ex-smoker for at least 3 months before screening
Locations
United States
Kansas
ICON Lenexa
RECRUITING
Lenexa
Contact Information
Primary
Medical Information
medicalinfo@vrtx.com
617-341-6777
Time Frame
Start Date: 2025-06-12
Estimated Completion Date: 2026-03-03
Participants
Target number of participants: 32
Treatments
Experimental: Part A: Single Ascending Dose
Participants will be randomized to receive a single dose of VX-407.
Placebo_comparator: Placebo Part A
Participants will be randomized to receive placebo matched to VX-407.
Experimental: Part B: Multiple Ascending Dose
Participants will be randomized to receive multiple doses of VX-407.
Placebo_comparator: Placebo Part B
Participants will be randomized to receive placebo matched to VX-407.
Related Therapeutic Areas
Sponsors
Leads: Vertex Pharmaceuticals Incorporated