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NCT07584434PHASE1RecruitingAccepts Healthy Volunteers

A Phase 1, First-in-human Study of VX-433

Vertex Pharmaceuticals Incorporated

Start Date

5/21/2026

Completion Date

3/5/2027

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.

Detailed Description

The study is being conducted in healthy participants to evaluate the safety, tolerability, and PK of VX-433 (Parts A and B), as well as potential drug-drug interaction (DDI) between VX-433 and midazolam or bupropion (Part C). Note: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria

Age Range: 18 years to 55 years

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.

Interventions

DRUG

VX-433

DRUG

Placebo

DRUG

Midazolam

DRUG

Bupropion

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Conditions

Narcolepsy Type 1 (NT1)

Locations

ICON - Utah - Salt Lake City Office

Salt Lake City, Utah 84124

United States