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RECRUITING Phase 1 ClinicalTrials.gov

Evaluation of VX-581 in Healthy Participants and in Participants With Cystic Fibrosis

Sponsor: Vertex Pharmaceuticals Incorporated • ClinicalTrials.gov ID: NCT07283770

Registry updated: 2026-10-19
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Description

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single dose of VX-581 and multiple ascending doses of VX-581 alone and in combination with tezacaftor (TEZ)/deutivacaftor (D-IVA) or D-IVA in healthy participants. The study will also evaluate the safety, tolerability, and pharmacokinetics of VX-581 administered in combination with D-IVA with or without TEZ in participants with cystic fibrosis (CF).

Interventions

  • VX-581 (Drug)
    Suspension for Oral Administration.
  • Placebo (Drug)
    Suspension for Oral Administration.
  • D-IVA (Drug)
    Tablet for Oral Administration.
  • TEZ (Drug)
    Tablet for Oral Administration.
  • ELX/TEZ/IVA (Drug)
    Fixed dose combination (FDC) Tablets for Oral Administration.
  • VX-581 (Drug)
    Tablets for Oral Administration.
  • IVA (Drug)
    Tablet for Oral Administration.

Eligibility criteria

Key Inclusion Criteria: * Parts A, B, C: * 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 * Part D: * Confirmed diagnosis of CF Key Exclusion Criteria: * Parts A, B, C: * History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * Any condition possibly affecting drug absorption * Part D: * History of clinically significant cirrhosis with or without portal hypertension. Other protocol defined Inclusion/Exclusion criteria may apply.

Conditions

Cystic Fibrosis

Locations

  • Altasciences - Kansas City — Overland Park, Kansas, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record