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: 128
• 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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

• 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 34

• 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 66

Secondary Outcomes (4)

• 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

Study Arms (4)

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

Interventions

VX-272 DRUG

Suspension for Oral Administration.

Part A: Single Ascending Dose; Part B: Multiple Ascending Dose

Placebo DRUG

Suspension for Oral Administration.

Placebo: Part A; Placebo: Part B

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

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): March 23, 2027
• Study Completion (Estimated): March 23, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)