Recruiting
Phase 1

VX-272

Sponsor:

Vertex Pharmaceuticals Incorporated

Code:

NCT07437105

Conditions

Cystic Fibrosis

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

VX-272

Placebo

Tezacaftor

Deutivacaftor

Study Details

Brief summary:

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of VX-272 in combination with deutivacaftor (D-IVA) with or without tezacaftor (TEZ) in healthy subjects.

Conditions

Cystic Fibrosis

Study ID

NCT07437105

Start date

Feb 25, 2026

Status verified date

Sep, 2026

Completion date

Jun 26, 2027

Anticipated

Primary completion date

Jun 26, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

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)
  • A total body weight of more than (>) 50 kg
  • Male and Female participants of non-childbearing potential

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

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: Single Ascending Dose

Participants will be randomized to receive a single dose of VX-272.

placebo comparator: Placebo: Part A

Participants will be randomized to receive a single dose of placebo matched to VX-272.

experimental: Part B: Multiple Ascending Dose

Participants will be randomized to receive multiple doses of VX-272.

placebo comparator: Placebo: Part B

Participants will be randomized to receive multiple doses of placebo matched to VX-272.

experimental: Part C: VX-272 in Combination With Tezacaftor (TEZ)/ Deutivacaftor (D-IVA) or D-IVA

Participants will be randomized to receive VX-272 in combination with TEZ/D-IVA or D-IVA.

placebo comparator: Placebo: Part C

Participants will be randomized to receive placebo matched to VX-272 in combination with TEZ/D-IVA or D-IVA.

Interventions

VX-272

Suspension for Oral Administration.

Placebo

Suspension for Oral Administration.

Tezacaftor

Tablet for oral administration.

Deutivacaftor

Tablet for oral administration.

Primary outcome measure

  • Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 34) ]
  • Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 66) ]
  • Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 66) ]

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

Sep 23, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Vertex Pharmaceuticals Incorporated on 2026-09-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.