Clinical trial NCT06336096: A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation and Strength of Suzetrigine
Official title: A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation of Suzetrigine in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2024-03-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.).

Eligibility 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/Exclusion criteria may apply.

Primary outcomes:
measure: Part A: Maximum Observed Plasma Concentration (Cmax) of SUZ
timeFrame: Pre-dose up to Day 43
measure: Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of SUZ
timeFrame: Pre-dose up to Day 43
measure: Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of SUZ
timeFrame: Pre-dose up to Day 43
measure: Part B: Cmax of SUZ
timeFrame: Pre-dose up to Day 29
measure: Part B: AUC0-tlast of SUZ
timeFrame: Pre-dose up to Day 29
measure: Part B: AUC0-inf of SUZ
timeFrame: Pre-dose up to Day 29
Secondary outcomes:
measure: Part A: Cmax of SUZ Metabolite
timeFrame: Pre-dose up to Day 43
measure: Part A: AUC0-tlast of SUZ Metabolite
timeFrame: Pre-dose up to Day 43
measure: Part A: AUC0-inf of SUZ Metabolite
timeFrame: Pre-dose up to Day 43
measure: Part A: Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 43
measure: Part B: Cmax of SUZ Metabolite
timeFrame: Pre-dose up to Day 29
measure: Part B: AUC0-tlast of SUZ Metabolite
timeFrame: Pre-dose up to Day 29
measure: Part B: AUC0-inf of SUZ Metabolite
timeFrame: Pre-dose up to Day 29
measure: Part B: Safety and Tolerability as Assessed by Number of Participants with AEs and SAEs
timeFrame: From Day 1 up to Day 29
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion - Tempe
state: Arizona
Study officials:
References: