A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation and Strength of Suzetrigine
- Registration Number
- NCT06336096
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- 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.).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part A Suzetrigine Participants will be randomized to receive a single dose of SUZ in 1 of 6 treatment sequences with 3 dosing periods to assess the relative bioavailability of two tablet formulations and the effect of food on the PK of SUZ. There will be a 14-day washout period between each dosing period. Part B Suzetrigine Participants will be randomized to receive a single dose of SUZ formulation in 1 of 2 treatment sequences with 2 dosing periods to assess the relative bioavailability of tablet formulation compared to a suspension of SUZ. There will be a 14-day washout period between each dosing period.
- Primary Outcome Measures
Name Time Method 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 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-inf of SUZ Pre-dose up to Day 29 Part B: AUC0-tlast of SUZ Pre-dose up to Day 29
- Secondary Outcome Measures
Name Time Method Part B: Cmax of SUZ Metabolite Pre-dose up to Day 29 Part A: Cmax 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: AUC0-inf of SUZ Metabolite Pre-dose up to Day 29 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 B: AUC0-tlast of SUZ Metabolite Pre-dose up to Day 29
Trial Locations
- Locations (1)
Celerion - Tempe
🇺🇸Tempe, Arizona, United States
Celerion - Tempe🇺🇸Tempe, Arizona, United States