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

NCT07437105
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
160
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Lead sponsor
Vertex Pharmaceuticals Incorporated
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Start date
2026-02-25
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Number of sites
1
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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.
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Short title
Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in Healthy Participants
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Official title
A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-272 in Healthy Subjects
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-06-26
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First posted
2026-02-27
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Registry last updated
2026-09-23
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Primary completion date
2027-06-26
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Start date
2026-02-25
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Participants
160
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Participant count basis
Estimated
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Planned participants
160
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Protocol amendments
2
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Number of sites
1
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Registry sponsor category
Industry
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Lead sponsor
Vertex Pharmaceuticals Incorporated
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07437105
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ClinicalTrials.gov ID
NCT07437105
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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)

  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
clinicaltrials.gov

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
clinicaltrials.gov

  • Celerion - TempeTempe, United StatesRecruiting
Sources for sites
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Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (1)