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

NCT ID: NCT06336096

Last Updated: 2024-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-28
• Study Completion Date: 2024-06-19

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.).

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A

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.

Group Type: EXPERIMENTAL

Suzetrigine

Intervention Type: DRUG

Tablet(s) for oral administration.

Part B

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.

Group Type: EXPERIMENTAL

Suzetrigine

Intervention Type: DRUG

Tablet(s) and Suspension for oral administration.

Interventions

Suzetrigine

Tablet(s) for oral administration.

Intervention Type: DRUG

Suzetrigine

Tablet(s) and Suspension for oral administration.

Intervention Type: DRUG

Other Intervention Names

VX-548; SUZ; VX-548; SUZ

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Celerion - Tempe

Tempe, Arizona, United States

Countries

United States

Other Identifiers

VX23-548-017

Identifier Type: -

Identifier Source: org_study_id