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A Phase 1, First-in-human Study of VX-433
A Phase 1, First-in-human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VX-433 and Its Effects on the Pharmacokinetics of Midazolam and Bupropion
Who can join
Ages 18 to 55 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Key Inclusion Criteria: * Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m2), inclusive * A total body weight of more 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 * For female participants: of childbearing potential, pregnant, breastfeeding, or planning to become pregnant or donate ova during the study or within 90 days after last dose of study drug Other protocol defined Inclusion/Exclusion criteria will apply.
About the study
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VX-433 following single and multiple ascending doses, as well as to assess the effect of VX-433 on the PK of midazolam, bupropion, and hydroxybupropion.
What is being tested
- VX-433 (drug)
- Placebo (drug)
- Midazolam (drug)
- Bupropion (drug)
Sponsor: Vertex Pharmaceuticals Incorporated · Participants: 118 · Started: May 21, 2026
Contact the study team
- Medical Information · Phone: 617-341-6777
Official record on ClinicalTrials.gov — NCT07584434
Locations in the U.S.
| Utah | ICON - Utah - Salt Lake City Office, Salt Lake City |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.