Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07584434 | A Phase 1, First-in-human Study of VX-433 | PHASE1 | RECRUITING | 118 | — | — | May 21, 2026 | Mar 5, 2027 | Jun 8, 2026 | 1 | United States |
| 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...