Recruiting
Phase 1

VX-433 with Midazolam

Sponsor:

Vertex Pharmaceuticals Incorporated

Code:

NCT07584434

Conditions

Narcolepsy Type 1 (NT1)

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

VX-433

Placebo

Midazolam

Bupropion

Study Details

Brief 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)

Study ID

NCT07584434

Start date

May 21, 2026

Status verified date

May, 2026

Completion date

Mar 5, 2027

Anticipated

Primary completion date

Mar 5, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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

Key Exclusion Criteria:

  • History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
  • Any condition possibly affecting drug absorption
  • For female participants: of childbearing potential, pregnant, breastfeeding, or planning to become pregnant or donate ova during the study or within 90 days after last dose of study drug

Other protocol defined Inclusion/Exclusion criteria will apply.

Study Design

Enrollment

118 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

VX-433

Suspension for Oral Administration

Placebo

Suspension for Oral Administration

Midazolam

Syrup for Oral Administration

Bupropion

Capsule for Oral Administration

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 ]
  • Part B: 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 18 ]
  • Part C: Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-433 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From Day 1 up to Day 22 ]

Central Contacts and Locations

Central contacts

Medical Information

617-341-6777medicalinfo@vrtx.com

Locations

ICON - Utah - Salt Lake City Office

Recruiting

Salt Lake City, Utah, United States, 84124

More Information

Sponsor

Vertex Pharmaceuticals Incorporated

Last update posted

Jun 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Vertex Pharmaceuticals Incorporated on 2026-06-08.