Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants

NCT07437105 | Recruiting Phase 1 FDA Drug

• 1 other identifier: VX25-272-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  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)

  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)

  From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 66)

Secondary Outcomes (8)

• Part A: Maximum Observed Plasma Concentration (Cmax) of VX-272

  From Day 1 up to Day 34

• Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of VX-272

  From Day 1 up to Day 34

• Part B: Maximum Observed Plasma Concentration (Cmax) of VX-272

  From Day 1 up to Day 66

• Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of VX-272

  From Day 1 up to Day 66

• Part C: Maximum Observed Plasma Concentration (Cmax) of VX-272 and its Metabolites

  From Day 1 up to Day 66

Study Arms (6)

Part A: Single Ascending Dose

EXPERIMENTAL

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

Drug: VX-272

Placebo: Part A

PLACEBO COMPARATOR

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

Drug: Placebo

Part B: Multiple Ascending Dose

EXPERIMENTAL

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

Drug: VX-272

Placebo: Part B

PLACEBO COMPARATOR

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

Drug: Placebo

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

EXPERIMENTAL

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

Drug: VX-272; Drug: Tezacaftor; Drug: Deutivacaftor

Placebo: Part C

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Tezacaftor; Drug: Deutivacaftor

Interventions

Tezacaftor DRUG

Tablet for oral administration.

Also known as: TEZ, VX-661

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

Deutivacaftor DRUG

Tablet for oral administration.

Also known as: D-IVA, VX-561

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

VX-272 DRUG

Suspension for Oral Administration.

Part A: Single Ascending Dose; Part B: Multiple Ascending Dose; Part C: VX-272 in Combination With Tezacaftor (TEZ)/ Deutivacaftor (D-IVA) or D-IVA

Placebo DRUG

Suspension for Oral Administration.

Placebo: Part A; Placebo: Part B; Placebo: Part C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

Celerion - Tempe

Tempe, Arizona, 85283, United States

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

tezacaftor; deutivacaftor, tezacaftor , vanzacaftor

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Central Study Contacts

Medical Information

CONTACT

617-341-6777; medicalinfo@vrtx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): June 26, 2027
• Study Completion (Estimated): June 26, 2027
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)