Recruiting
Phase 1

VX-581

Sponsor:

Vertex Pharmaceuticals Incorporated

Code:

NCT07813039

Conditions

Cystic Fibrosis

Eligibility Criteria

Sex: Male

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

VX-581

Study Details

Brief summary:

The purpose of this study is to evaluate the relative bioavailability of VX-581 tablet formulation compared to a suspension formulation along with its safety and tolerability.

Conditions

Cystic Fibrosis

Study ID

NCT07813039

Start date

Sep 23, 2026

Status verified date

Oct, 2026

Completion date

Oct 27, 2026

Anticipated

Primary completion date

Oct 27, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 55

Healthy Volunteers: Accepted

Key Inclusion Criteria:

  • Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2), inclusive
  • Total body weight of greater than (>) 50 kg
  • Nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screening

Key Exclusion Criteria:

  • 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

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

16 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sequence 1

Participants will be randomized to receive VX-581 suspension in dosing period 1 followed by VX-581 tablet in dosing period 2. A washout period of 10 days will be maintained between the 2 dosing periods.

experimental: Sequence 2

Participants will be randomized to receive VX-581 tablet in dosing period 1 followed by VX-581 suspension in dosing period 2. A washout period of 10 days will be maintained between the 2 dosing periods.

Interventions

VX-581

Tablet and Suspension for Oral Administration.

Primary outcome measure

  • Maximum Observed Plasma Concentration (Cmax) of VX-581 [ Time Frame: Period 1 and Period 2: From Day 1 up to Day 21 ]
  • Area Under the Concentration Versus Time Curve (AUC) of VX-581 [ Time Frame: Period 1 and Period 2: From Day 1 up to Day 21 ]

Central Contacts and Locations

Central contacts

Medical Information

617-341-6777medicalinfo@vrtx.com

Locations

Celerion - Tempe

Recruiting

Tempe, Arizona, United States, 85283

More Information

Sponsor

Vertex Pharmaceuticals Incorporated

Last update posted

Oct 19, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-20. This information was provided to ClinicalTrials.gov by Vertex Pharmaceuticals Incorporated on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.