Pain
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of VX-973 in healthy participants.
Detailed description
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-973
Suspension for oral administration.
DRUGPlacebo
Suspension for oral administration.
DRUGMidazolam
Syrup 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 32.0 kilogram per meter square (kg/m\^2) * A total body weight of more than (\>) 50 kg * Participants of non-childbearing potential * Nonsmoker or ex-smoker for at least 3 months before 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 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 31 |
| 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 43 |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-973 | From Day 1 up to Day 30 |
| Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-973 | From Day 1 up to Day 43 |
| Part A: Maximum Observed Plasma Concentration (Cmax) of VX-973 | From Day 1 up to Day 30 |
| Part B: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in the Absence and Presence of VX-973 | Days -1 and 27: Pre-dose up to 24 hours Post Midazolam dose |
| Part B: Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-973 | Days -1 and 27: Pre-dose up to 24 hours Post Midazolam dose |
| Part B: Maximum Observed Plasma Concentration (Cmax) of VX-973 | From Day 1 up to Day 43 |
Countries
United Kingdom
Outcome results
None listed