Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07584434

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON - Utah - Salt Lake City Office

Salt Lake City, Utah, 84124, United States

Location status: Recruiting

About this study

The study is being conducted in healthy participants to evaluate the safety, tolerability, and PK of VX-433 (Parts A and B), as well as potential drug-drug interaction (DDI) between VX-433 and midazolam or bupropion (Part C).

Note: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. Part A: Maximum Observed Plasma Concentration (Cmax) of VX-433

    Time frame: From Day 1 up to Day 6

  2. Part B: Maximum Observed Plasma Concentration (Cmax) of VX-433

    Time frame: From Day 1 up to Day 18

  3. Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-433

    Time frame: From Day 1 up to Day 6

  4. Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-433

    Time frame: From Day 1 up to Day 18

  5. Part A: Time Required for Plasma Concentration of VX-433 to Reduce to Half (t1/2)

    Time frame: From Day 1 up to Day 6

  6. Part B: Time Required for Plasma Concentration of VX-433 to Reduce to Half (t1/2)

    Time frame: From Day 1 up to Day 18

  7. Part A: Renal Clearance (CLr) of VX-433

    Time frame: From Day 1 up to Day 2

  8. Part B: Renal Clearance (CLr) of VX-433

    Time frame: From Day 1 up to Day 11

  9. Part A: Amount of VX-433 excreted in Urine

    Time frame: From Day 1 up to Day 2

  10. Part B: Amount of VX-433 excreted in Urine

    Time frame: From Day 1 up to Day 11

  11. Part C: 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 29

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Information

CONTACT

[email protected]

617-341-6777

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Phase 1, First-in-human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VX-433 and Its Effects on the Pharmacokinetics of Midazolam and Bupropion

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 13, 2026
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.