Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VX-433 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part A: Single Ascending Dose (SAD) | EXPERIMENTAL | Participants will be randomized to receive a single dose of VX-433. |
| Part A: Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive placebo matched to VX-433. |
| Part B: Multiple Ascending Dose (MAD) | EXPERIMENTAL | Participants will be randomized to receive multiple doses of VX-433. |
| Part B: Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive placebo matched to VX-433. |
| Part C: Drug Drug Interaction | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 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 |
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...
VX-433 is an investigational small molecule being developed for the treatment of Narcolepsy Type 1 (NT1). It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in a first-in-human trial to evaluate its safety and tolerability in healthy volunteers and participants with NT1.
VX-433 is a small molecule developed by Vertex Pharmaceuticals for Narcolepsy Type 1. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being investigated for its potential to address the underlying pathophysiology of NT1, though the exact mechanism of action remains under study.
VX-433 is being developed by Vertex Pharmaceuticals Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VRTX. Vertex is conducting a Phase 1 clinical trial of VX-433 for Narcolepsy Type 1 in the United States.
VX-433 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 study is a first-in-human trial designed to assess the safety, tolerability, and pharmacokinetics of VX-433 in healthy volunteers and individuals with Narcolepsy Type 1.
VX-433 is being evaluated in a single Phase 1 clinical trial registered as NCT07584434. This is a first-in-human, randomized, double-blind, placebo-controlled study with an estimated enrollment of 118 participants. The trial is currently recruiting in the United States and includes healthy volunteers aged 18 years and older.
VX-433 is a distinct investigational compound developed by Vertex Pharmaceuticals. No alternative names for VX-433 have been reported in clinical trial registrations. It is being studied specifically for Narcolepsy Type 1 and is not known to be identical to any other marketed or investigational drug.