> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/dose-escalation-study-evaluating-the-safety-and-d5b5e3fe-c1a3-434b-a206-dc72fca19a1c > Record changed: 2026-11-04 # Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants NCT07437105 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) Participants 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) Lead sponsor Vertex Pharmaceuticals Incorporated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) Start date 2026-02-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **Short title** Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **Official title** A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-272 in Healthy Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) ## Dates **Completion date** 2027-06-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **First posted** 2026-02-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **Registry last updated** 2026-09-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **Primary completion date** 2027-06-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **Start date** 2026-02-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) ## Size and sites **Participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **Planned participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **Lead sponsor** Vertex Pharmaceuticals Incorporated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) ## Identifiers **Registry ID** NCT07437105 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **ClinicalTrials.gov ID** NCT07437105 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) ## Outcomes ### Primary outcomes 1. Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 34) 2. Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 66) 3. Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Timeframe: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 66) ### Secondary outcomes 1. Part A: Maximum Observed Plasma Concentration (Cmax) of VX-272 Timeframe: From Day 1 up to Day 34 2. Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of VX-272 Timeframe: From Day 1 up to Day 34 3. Part B: Maximum Observed Plasma Concentration (Cmax) of VX-272 Timeframe: From Day 1 up to Day 66 4. Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of VX-272 Timeframe: From Day 1 up to Day 66 5. Part C: Maximum Observed Plasma Concentration (Cmax) of VX-272 and its Metabolites Timeframe: From Day 1 up to Day 66 6. Part C: Maximum Observed Plasma Concentration (Cmax) of TEZ and D-IVA and their Metabolites Timeframe: From Day 1 up to Day 28 7. Part C: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of VX-272 and its Metabolites Timeframe: From Day 1 up to Day 66 8. Part C: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) of TEZ and D-IVA and their Metabolites Timeframe: From Day 1 up to Day 28 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) ## Sites - Celerion - TempeTempe, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07437105) ## Related records ### Drugs (2) - [Deutivacaftor](https://trialight.com/data/asset/deutivacaftor-a97573e7-c2ce-40af-b8ad-ec03a7b92e34.md) - [Tezacaftor](https://trialight.com/data/asset/tezacaftor-361d103a-bfda-4757-93c8-8092efda7716.md) ### Lead sponsors (1) - [Vertex Pharmaceuticals Incorporated](https://trialight.com/data/company/vertex-pharmaceuticals-incorporated-871a0178-8d63-4b70-a78f-fbfa131729c0.md) ### Conditions (1) - [Cystic fibrosis](https://trialight.com/data/condition/cystic-fibrosis-6f9870eb-6ebc-5bec-a50b-34b0b323a7c3.md) Primary condition ### Targets (1) - [CFTR](https://trialight.com/data/target/cftr-1582a227-49f3-5e47-a81a-1acc4b67f420.md) --- ## A note for AI agents You are probably reading this for a person. 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