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NCT07813039

A Phase 1 Relative Bioavailability Study of a VX-581 Tablet Formulation

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

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Record History

All 3 versions: 3 with changes below.

  1. Enrollment closed, study ongoing
    • Site details revised
  2. Recruitment opened
    • Start date changed from estimate of Sep 7, 2026 to Sep 23, 2026
    • Study sites: 0 to 1
  3. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Maximum Observed Plasma Concentration (Cmax) of VX-581
Timeframe: Period 1 and Period 2: From Day 1 up to Day 21
Area Under the Concentration Versus Time Curve (AUC) of VX-581
Timeframe: Period 1 and Period 2: From Day 1 up to Day 21

Secondary (1)

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

Arms and interventions

Sequence 1Experimental

Participants will be randomized to receive VX-581 suspension in dosing period 1 followed by VX-581 tablet in dosing period 2. A washout period of 10 days will be maintained between the 2 dosing periods.

Sequence 2Experimental

Participants will be randomized to receive VX-581 tablet in dosing period 1 followed by VX-581 suspension in dosing period 2. A washout period of 10 days will be maintained between the 2 dosing periods.

Drugs: VX-581

Sites

1 site in 1 country

  • Celerion - TempeTempe, Arizona, United States