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

RecruitingPhase 1Ages 18 Years - 55 YearsAllVertex Pharmaceuticals Incorporated
NCT07283770 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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.
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What it tests

  • VX-581
  • Placebo
  • D-IVA
  • TEZ
  • ELX/TEZ/IVA
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Where

1 site
Altasciences - Kansas City
Overland Park, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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