A Phase 1, First-in-human Study of VX-433
← catalyst calendarNCT07584434 · readout in 198 d
Sponsored by Vertex Pharmaceuticals Incorporated (industry) · VRTX — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
118estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-05-21 | actual | When the study began enrolling |
| Primary completion | 2027-03-05 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-03-05 | estimated | The whole study's end, after follow-up |
| First posted | 2026-05-13 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Narcolepsy Type 1 (NT1)
Interventions
- Drug: VX-433
- Drug: Placebo
- Drug: Midazolam
- Drug: Bupropion
Primary outcomes
what the primary-completion date above is the date OFPart A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
measured From Day 1 up to Day 6
Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
measured From Day 1 up to Day 18
Part C: Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-433
measured From Day 1 up to Day 22
Part C: Maximum Observed Plasma Concentration (Cmax) of Bupropion and Hydroxybupropion in the Absence and Presence of VX-433
measured From Day 1 up to Day 22
Part C: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in the Absence and Presence of VX-433
measured From Day 1 up to Day 22
Part C: Area Under the Concentration Versus Time Curve (AUC) of Bupropion and Hydroxybupropion in the Absence and Presence of VX-433
measured From Day 1 up to Day 22
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