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RecruitingAccepts healthy volunteersPhase 1

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

Vertex Pharmaceuticals Incorporated · NCT07283770

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–55 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
152
US sites recruiting
1
Study start
December 9, 2025
Record last updated
October 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: VX-581; Placebo; D-IVA; TEZ; ELX/TEZ/IVA; VX-581; IVA

Conditions: Cystic Fibrosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

Study contacts (from the official record)

  • Medical Information · 617-341-6777 · medicalinfo@vrtx.com
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Evaluation of VX-581 in Healthy Participants and in Participants… (NCT07283770) | Bored Studies