NCT07584434
A Phase 1, First-in-human Study of VX-433
Recruiting
PHASE1Ages 18–55InterventionalTreatmentVertex Pharmaceuticals Incorporated
~118 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:VX-433PlaceboMidazolamBupropion
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured over From Day 1 up to Day 6
+5 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesUtah1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
Exclusion
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
What this trial measures
- Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)From Day 1 up to Day 6
- Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)From Day 1 up to Day 18
- Part C: Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-433From Day 1 up to Day 22
- Part C: Maximum Observed Plasma Concentration (Cmax) of Bupropion and Hydroxybupropion in the Absence and Presence of VX-433From Day 1 up to Day 22
- Part C: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in the Absence and Presence of VX-433From Day 1 up to Day 22
- Part C: Area Under the Concentration Versus Time Curve (AUC) of Bupropion and Hydroxybupropion in the Absence and Presence of VX-433From Day 1 up to Day 22