VX-581 Safety Study in Healthy Adults

This study is testing a new medication called VX-581, which is given as a liquid by mouth. Researchers want to understand how safe VX-581 is, how well your body tolerates it, and how it moves through your system. They are testing VX-581 alone and in combination with other cystic fibrosis medications, tezacaftor (TEZ) and deutivacaftor (D-IVA). This study is looking for healthy volunteers between 18 and 55 years old. The main goal is to track any side effects (adverse events) that participants might experience. The study is currently unclear on its recruitment status and plans to enroll 136 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It involves different parts where VX-581 is given alone or with other medications, or a placebo (an inactive substance).
What's involved
You would go through a screening phase, a treatment phase where you receive the study medication for up to 10 days, and a safety follow-up phase.
Compensation
Not stated in the trial record.
Follow-up
Safety will be monitored for up to 8 days after the last dose in Part A, and up to 17 days after the last dose in Parts B and C.

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NCT07283770

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

Recruiting
PHASE1Ages 18–55InterventionalTreatment
Vertex Pharmaceuticals Incorporated
~136 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:VX-581PlaceboD-IVATEZ

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured over From Day -1 up to Day 8
+2 more outcomes measured
Cystic Fibrosis
1 sites across 1 states
Kansas1

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Eligibility criteria

Inclusion

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

Exclusion

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 A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)From Day -1 up to Day 8
  • Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)From Day -1 up to Day 17
  • Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)From Day -1 up to Day 17