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

NCT07584434 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Narcolepsy Type 1 (NT1)

Interventions

DRUG

VX-433

Suspension for Oral Administration

DRUG

Placebo

Suspension for Oral Administration

DRUG

Midazolam

Syrup for Oral Administration

DRUG

Bupropion

Capsule for Oral Administration

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-12
Primary Completion
2027-03-05
Completion
2027-03-05
FDA Drug
Yes

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07584434 on ClinicalTrials.gov