VX-433 first‑in‑human safety and PK study in healthy volunteers
Official title: 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
Run by Vertex Pharmaceuticals Incorporated · NCT07584434 · Data updated 2026-11-12
This study tests the safety, how VX-433 behaves in the body, and possible drug interactions in healthy adults, to see if it’s suitable for people with narcolepsy type 1 in the future.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 118 (estimated) |
| Sponsor | Vertex Pharmaceuticals Incorporated Industry-sponsored |
| Locations | 1 site (Salt Lake City, Utah) |
| Status | Recruiting |
| Started | May 21, 2026 |
| Main results expected | March 5, 2027 |
| Study ends | March 5, 2027 |
| Registry record updated | June 8, 2026 |
| Trial ID | NCT07584434 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults who meet BMI, weight, smoking status, and general health criteria and who can comply with study procedures.
✕Probably not a fit
Participants who do not show favorable safety or pharmacokinetic results for VX-433 or who have conditions affecting drug absorption or overall health may not experience a benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, first‑in‑human trial evaluating VX-433 in healthy volunteers. It includes single and multiple ascending dose parts to assess safety, tolerability, and pharmacokinetics, plus a drug‑drug interaction sub‑study with midazolam and bupropion. Part A and B focus on VX-433 alone, while Part C examines how VX-433 may affect the PK of other medications. The study is sponsored by Vertex with ICON Utah as the site providing the research infrastructure.
Why it matters
Potential benefit: If successful, VX-433 could be a foundation for future therapies, potentially informing dosing and safety for patients with narcolepsy type 1 in later trials.
How similar studies have gone: First‑in‑human studies of similar CNS‑targeted agents have shown safety signals can guide later development, but this exact VX‑433 program is novel in this context.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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ICON - Utah - Salt Lake City Office
Salt Lake City, Utah, United States Recruiting
Study contacts
- Study coordinator: Medical Information
- Email: medicalinfo@vrtx.com
- Phone: 617-341-6777
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Ofatumumab for drug-refractory Narcolepsy Type 1
Aims to see if a single dose of ofatumumab helps people with Narcolepsy Type 1 who have not responded to previous treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.