A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-581 in Healthy Subjects
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VX-581.
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 more than (\>) 50 kg
• Male and Female participants of non-childbearing potential
Locations
United States
Kansas
Altasciences - Kansas City
RECRUITING
Overland Park
Contact Information
Primary
Medical Information
medicalinfo@vrtx.com
617-341-6777
Time Frame
Start Date: 2025-12-09
Estimated Completion Date: 2026-11-19
Participants
Target number of participants: 128
Treatments
Experimental: Part A: Single Ascending Dose
Participants will be randomized to receive a single dose of VX-581.
Placebo_comparator: Placebo: Part A
Participants will be randomized to receive a single dose of placebo matched to VX-581.
Experimental: Part B: Multiple Ascending Dose
Participants will be randomized to receive multiple doses of VX-581.
Placebo_comparator: Placebo: Part B
Participants will be randomized to receive multiple doses of placebo matched to VX-581.
Related Therapeutic Areas
Sponsors
Leads: Vertex Pharmaceuticals Incorporated