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

NCT06336096 | Completed Phase 1 FDA Drug

• 1 other identifier: VX23-548-017
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (6)

• 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-tlast of SUZ

  Pre-dose up to Day 29

• Part B: AUC0-inf of SUZ

  Pre-dose up to Day 29

Secondary Outcomes (8)

• Part A: Cmax of SUZ Metabolite

  Pre-dose up to Day 43

• 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

Study Arms (2)

Part A

EXPERIMENTAL

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.

Drug: Suzetrigine

Part B

EXPERIMENTAL

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.

Drug: Suzetrigine

Interventions

Suzetrigine DRUG

Tablet(s) for oral administration.

Also known as: VX-548, SUZ

Part A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

Celerion - Tempe

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: March 28, 2024
• Primary Completion: June 19, 2024
• Study Completion: June 19, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)