Pain
Conditions
Brief summary
The purpose of this study is to evaluate the pharmacokinetics (PK) of suzetrigine (SUZ; VX-548) and its metabolite along with its safety and tolerability, 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
DRUGSuzetrigine
Tablet(s) for oral administration.
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
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 greater than (\>) 50 kilogram (kg) * Participants of non-childbearing potential 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: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of SUZ | Pre-dose up to Day 43 |
| Part B: Cmax of SUZ | Pre-dose up to Day 29 |
| Part B: AUC0-tlast of SUZ | Pre-dose up to Day 29 |
| Part B: AUC0-inf of SUZ | Pre-dose up to Day 29 |
| Part A: Maximum Observed Plasma Concentration (Cmax) of SUZ | Pre-dose up to Day 43 |
| Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of SUZ | Pre-dose up to Day 43 |
Secondary
| Measure | Time frame |
|---|---|
| Part B: AUC0-inf of SUZ Metabolite | Pre-dose up to Day 29 |
| Part A: Cmax of SUZ Metabolite | Pre-dose up to Day 43 |
| Part B: Safety and Tolerability as Assessed by Number of Participants with AEs and SAEs | From Day 1 up to Day 29 |
| Part A: AUC0-tlast of SUZ Metabolite | Pre-dose up to Day 43 |
| Part A: AUC0-inf of SUZ Metabolite | Pre-dose up to Day 43 |
| 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 43 |
| Part B: Cmax of SUZ Metabolite | Pre-dose up to Day 29 |
| Part B: AUC0-tlast of SUZ Metabolite | Pre-dose up to Day 29 |
Countries
United States
Outcome results
None listed