A Study to Evaluate the Relative Bioavailability and Food Effect of a New Tablet Formulation and Strength of Suzetrigine

Vertex Pharmaceuticals Incorporated48 enrolled

Overview

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.

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.).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain

Interventions

SuzetrigineDRUG

Tablet(s) for oral administration.

SuzetrigineDRUG

Tablet(s) and Suspension for oral administration.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Celerion - Tempe

Tempe, Arizona, United States

Outcomes

Primary Outcomes

Part A: Maximum Observed Plasma Concentration (Cmax) of SUZ

Time frame: 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

Time frame: 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

Time frame: Pre-dose up to Day 43

Part B: Cmax of SUZ

Time frame: Pre-dose up to Day 29

Part B: AUC0-tlast of SUZ

Time frame: Pre-dose up to Day 29

Part B: AUC0-inf of SUZ

Time frame: Pre-dose up to Day 29

Secondary Outcomes

Part A: Cmax of SUZ Metabolite

Time frame: Pre-dose up to Day 43

Part A: AUC0-tlast of SUZ Metabolite

Time frame: Pre-dose up to Day 43

Part A: AUC0-inf of SUZ Metabolite

Time frame: 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)

Time frame: From Day 1 up to Day 43

Part B: Cmax of SUZ Metabolite

Time frame: Pre-dose up to Day 29

Data from ClinicalTrials.gov

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