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NCT07283770

Evaluation of VX-581 in Healthy Participants and in Participants With Cystic Fibrosis

StatusRecruiting
PhasePhase 1
Primary completion (estimated)

At risk: Primary completion moved at least 7 months later, primary endpoint(s) modified.

See at-risk trials from Vertex Pharmaceuticals

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Record History

All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Nov 19, 2026 to Jul 12, 2027 Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 136 → 152 participants
    • Interventions modified
    • Trial arms changed: 6 → 7
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints: 6 to 9
    • Study description expanded, about 3 words
    • Study title shortened, about 1 word
  2. Eligibility criteria shortened, about 3 words
  3. Primary endpoint(s) modifiedv4 Show 5 more changesShow less
    • Trial arms changed: 4 → 6
    • Enrollment target: 128 to 136
    • Interventions: Placebo (Drug), VX-581 (Drug) to D-IVA (Drug), Placebo (Drug), TEZ (Drug), VX-581 (Drug)
    • Secondary endpoints: 4 to 6
    • Study description expanded, about 19 words
  4. Secondary endpoints revised (4)v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 5, 2025 to Dec 9, 2025
    v2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From Day -1 up to Day 8
Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From Day -1 up to Day 17
Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From Day -1 up to Day 17
Part D: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From Signing of Informed Consent up to Day 105

Secondary (9)

Part A: Maximum Observed Plasma Concentration (Cmax) of VX-581
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Up to 24 Hours (AUC0-24h) Post-Dose of VX-581
Part B: Cmax of VX-581
Part B: AUC0-24h Post-Dose of VX-581
Part C: Cmax of VX-581, TEZ (if administered), D-IVA and their Metabolite(s)
Show 4 moreShow less
Part C: AUC0-24h Post Dose of VX-581, TEZ (if administered), D-IVA and their Metabolite(s)
Part D: Cmax of VX-581, TEZ (if administered), D-IVA and their Metabolite(s)
Part D: AUC0-24h Post Dose of VX-581, TEZ (if administered), D-IVA and their Metabolite(s)
Part D: Absolute Change in Sweat Chloride (SwCl)

Arms and interventions

Part A: Single Ascending DoseExperimental

Participants will be randomized to receive a single dose of VX-581.

Placebo: Part APlacebo comparator

Participants will be randomized to receive a single dose of placebo matched to VX-581.

Part B: Multiple Ascending DoseExperimental

Participants will be randomized to receive multiple doses of VX-581.

Placebo: Part BPlacebo comparator

Participants will be randomized to receive multiple doses of placebo matched to VX-581.

Part C: VX-581 with TEZ/D-IVA or D-IVAExperimental

Participants will be randomized to receive multiple doses VX-581 in combination with TEZ/D-IVA or D-IVA.

Placebo: Part CPlacebo comparator

Participants will be randomized to receive placebo matched to VX-581 in combination with TEZ/D-IVA or D-IVA.

Part D: VX-581 with TEZ/D-IVA or D-IVA in CFExperimental

Participants with CF will enter a run-in period and receive ELX/TEZ/IVA. Following the run-in period participants will receive VX-581 in combination with TEZ/D-IVA or D-IVA in the treatment period. Following the treatment period, participants will enter a 14-day Washout Period and receive ELX/TEZ/IVA. (Part D will be open-label)

Drugs: VX-581, Placebo, D-IVA, TEZ, ELX/TEZ/IVA, IVA

Sites

1 site in 1 country

  • Altasciences - Kansas CityOverland Park, Kansas, United States