A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability of a Tablet Formulation of VX-581 in Healthy Adult Subjects
| Registry | NCT07813039 |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional; randomized, crossover, masking: none, treatment |
| Enrollment | 16 (Estimated) |
| Sponsor | Vertex Pharmaceuticals Incorporated (Industry) |
| Conditions | Cystic Fibrosis |
| Interventions | VX-581 (Drug) |
| Dates | start 2026-09-23, primary completion 2026-10-27 (estimated), completion 2026-10-27 (estimated), first posted 2026-09-10, last updated 2026-10-19 |
| Locations | 1 site in United States |
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The purpose of this study is to evaluate the relative bioavailability of VX-581 tablet formulation compared to a suspension formulation along with its safety and tolerability.
The purpose of this study is to evaluate the relative bioavailability of VX-581 tablet formulation compared to a suspension formulation along with its safety and tolerability in healthy human participants. Note: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Sequence 1 | Experimental | Drug: VX-581 | 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 2 | Experimental | Drug: VX-581 | 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. |
Sex: Male, ages: 18 Years to 55 Years, accepts healthy volunteers
Key Inclusion Criteria: * Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2), inclusive * Total body weight of greater than (>) 50 kg * Nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screening 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Celerion - Tempe | Tempe, Arizona | United States | Recruiting |