NCT07584434 A Phase 1, First-in-human Study of VX-433
| NCT ID | NCT07584434 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Vertex Pharmaceuticals Incorporated |
| Condition | Narcolepsy Type 1 (NT1) |
| Study Type | INTERVENTIONAL |
| Enrollment | 118 participants |
| Start Date | 2026-05-21 |
| Primary Completion | 2027-03-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 118 participants in total. It began in 2026-05-21 with a primary completion date of 2027-03-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07584434 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Narcolepsy Type 1 (NT1). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07584434 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07584434 currently recruiting?
Yes, NCT07584434 is actively recruiting participants. Contact the research team at medicalinfo@vrtx.com for enrollment information.
Where is the NCT07584434 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT07584434 clinical trial?
NCT07584434 is sponsored by Vertex Pharmaceuticals Incorporated. The trial plans to enroll 118 participants.