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Recruiting
NCT07584434
A Phase 1, First-in-human Study of VX-433
Conditions: Narcolepsy Type 1 (NT1)
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 118
Sponsor: Vertex Pharmaceuticals Incorporated
Location: ICON - Utah - Salt Lake City Office Salt Lake City Utah
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.
Source: ClinicalTrials.gov (NCT07584434). StuddyBuddy aggregates publicly available trial information.