Pain
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-993 at different doses 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-993
Suspension for oral administration.
DRUGPlacebo
Suspension 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 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) | Day 1 up to Day 25 |
| Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to Day 25 |
| Part B: Safety and Tolerability as Assessed by Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | Pre-dose up to Day 25 |
Secondary
| Measure | Time frame |
|---|---|
| Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993 | Pre-dose up to Day 25 |
| Part A: Maximum Observed Plasma Concentration (Cmax) of VX-993 | Pre-dose up to Day 25 |
| Part B: Pain Tolerance Threshold (PTT) for the Cold Pressor Test | Day 1, Day 10, and Day 11 |
| Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993 | Pre-dose up to Day 25 |
| Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-993 | Pre-dose up to Day 25 |
Countries
United Kingdom
Outcome results
None listed