A Phase 1, First-in-human Study of VX-433
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VX-433, Placebo, Midazolam, Bupropion.
- Who it may be relevant to
- Registry conditions: Narcolepsy Type 1 (NT1). Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Detailed description
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.).
Interventions
- Drug VX-433
Suspension for Oral Administration - Drug Placebo
Suspension for Oral Administration - Drug Midazolam
Syrup for Oral Administration - Drug Bupropion
Capsule for Oral Administration
Primary outcome measures
- 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]
Secondary outcome measures (11)
- Part A: Maximum Observed Plasma Concentration (Cmax) of VX-433 [Time frame: From Day 1 up to Day 6]
- Part B: Maximum Observed Plasma Concentration (Cmax) of VX-433 [Time frame: From Day 1 up to Day 18]
- Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-433 [Time frame: From Day 1 up to Day 6]
- Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-433 [Time frame: From Day 1 up to Day 18]
- 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]
- 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]
- Part A: Renal Clearance (CLr) of VX-433 [Time frame: From Day 1 up to Day 2]
- Part B: Renal Clearance (CLr) of VX-433 [Time frame: From Day 1 up to Day 11]
- Part A: Amount of VX-433 excreted in Urine [Time frame: From Day 1 up to Day 2]
- Part B: Amount of VX-433 excreted in Urine [Time frame: From Day 1 up to Day 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]
Eligibility criteria
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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- ICON - Utah - Salt Lake City Office — Salt Lake City
Identifiers
NCT: NCT07584434 · VX25-433-001