Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Vertex Pharmaceuticals Incorporated
Study ID
NCT07283770
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • VX-581 — DRUG
    Suspension for Oral Administration.
  • Placebo — DRUG
    Suspension for Oral Administration.

Study Details

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of VX-581.

Key Dates

Start date
Dec 9, 2025
Status verified
Dec 2025
Primary completion
Nov 19, 2026
Completion
Nov 19, 2026

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From Day -1 up to Day 8 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Altasciences - Kansas CityOverland ParkKansas66212-

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Altasciences - Kansas City· Overland Park, KS

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