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

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
Vertex Pharmaceuticals Incorporated
Study ID
NCT07584434
Phase
PHASE1
Status
Recruiting
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Conditions

  • Narcolepsy Type 1 (NT1)

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • VX-433 — DRUG
    Suspension for Oral Administration
  • Placebo — DRUG
    Suspension for Oral Administration
  • Midazolam — DRUG
    Syrup for Oral Administration
  • Bupropion — DRUG
    Capsule for Oral Administration

Study Details

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.

Key Dates

Start date
May 21, 2026
Status verified
May 2026
Primary completion
Mar 5, 2027
Completion
Mar 5, 2027

Study Design

Enrollment
118 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Single Ascending Dose (SAD)
    Participants will be randomized to receive a single dose of VX-433.
  • Placebo Comparator: Part A: Placebo
    Participants will be randomized to receive placebo matched to VX-433.
  • Experimental: Part B: Multiple Ascending Dose (MAD)
    Participants will be randomized to receive multiple doses of VX-433.
  • Placebo Comparator: Part B: Placebo
    Participants will be randomized to receive placebo matched to VX-433.
  • Experimental: Part C: Drug Drug Interaction
    Participants will receive a single dose of midazolam and bupropion on Day 1 in Dosing Period 1, followed by VX-433 administration for 17 days (Days 5 through 21) and then midazolam and bupropion on Day 18 in Dosing Period 2. Part C will be open-label.

Primary Outcome Measure

Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From Day 1 up to Day 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIP
ICON - Utah - Salt Lake City OfficeSalt Lake CityUtah84124

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ICON - Utah - Salt Lake City Office· Salt Lake City, UT

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