Actively Recruiting
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
Led by Vertex Pharmaceuticals Incorporated · Updated on 2026-06-08
118
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and pharmacokinetics of VX-433, a drug given orally, in healthy adults. This Phase 1 study also examines how VX-433 affects the pharmacokinetics of two other drugs, midazolam and bupropion. The trial is conducted in multiple parts to assess single and multiple doses, as well as potential drug interactions. Participants are randomly assigned to receive either a single dose or multiple doses of VX-433 or a matching placebo. In a separate open-label part, participants receive midazolam and bupropion followed by VX-433 to study drug interactions. VX-433 and placebo are given as oral suspensions, while midazolam is given as a syrup and bupropion as a capsule. The dosing and assessment periods vary by study part, ranging from a few days to several weeks. During the study, participants undergo safety monitoring, including tracking of adverse events and serious adverse events. Blood samples are collected to measure drug concentrations and pharmacokinetic parameters such as maximum plasma concentration and area under the concentration-time curve. The study also monitors drug excretion in urine and evaluates drug interactions over a total period of up to 29 days. Participants are healthy volunteers aged 18 to 55 years with specific weight and smoking history criteria.
CONDITIONS
Brief Title
A Phase 1, First-in-human Study of VX-433
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 22 days
Participants receive study drug dosing including single or multiple doses of VX-433 or placebo, and in Part C, also receive midazolam and bupropion to study drug interactions.
Multiple visits over dosing periods, including Day 1, Days 5 through 21, and Day 18
Duration - Up to 7 days after last dose
Participants are monitored for safety and tolerability after dosing completion.
Approximately 1 to 2 follow-up visits
Trial Site Locations
Total: 1 location
1
ICON - Utah - Salt Lake City Office
Salt Lake City, Utah, United States, 84124
Actively Recruiting
Research Team
M
Medical Information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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