Narcolepsy Type 1 (NT1)
Conditions
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.
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
DRUGVX-433
Suspension for Oral Administration
DRUGPlacebo
Suspension for Oral Administration
DRUGMidazolam
Syrup for Oral Administration
DRUGBupropion
Capsule for Oral Administration
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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) | From Day 1 up to Day 18 |
| Part C: Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-433 | 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 | 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 | 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 | From Day 1 up to Day 22 |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Maximum Observed Plasma Concentration (Cmax) of VX-433 | From Day 1 up to Day 6 |
| Part B: Maximum Observed Plasma Concentration (Cmax) of VX-433 | From Day 1 up to Day 18 |
| Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-433 | From Day 1 up to Day 6 |
| Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-433 | From Day 1 up to Day 18 |
| Part A: Time Required for Plasma Concentration of VX-433 to Reduce to Half (t1/2) | From Day 1 up to Day 6 |
| Part B: Time Required for Plasma Concentration of VX-433 to Reduce to Half (t1/2) | From Day 1 up to Day 18 |
| Part A: Renal Clearance (CLr) of VX-433 | From Day 1 up to Day 2 |
| Part B: Renal Clearance (CLr) of VX-433 | From Day 1 up to Day 11 |
| Part A: Amount of VX-433 excreted in Urine | From Day 1 up to Day 2 |
| Part B: Amount of VX-433 excreted in Urine | 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) | From Day 1 up to Day 29 |
Countries
United States
Contacts
CONTACTMedical Information
Outcome results
None listed