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Completed

NCT Number: NCT06336096

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

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion - Tempe

Tempe, Arizona, 85283, United States

About this study

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.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Suzetrigine

Drug

Tablet(s) for oral administration.

Other names: VX-548, SUZ

Primary outcomes

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

    Time frame: Pre-dose up to Day 43

  2. 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

  3. 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

  4. Part B: Cmax of SUZ

    Time frame: Pre-dose up to Day 29

  5. Part B: AUC0-tlast of SUZ

    Time frame: Pre-dose up to Day 29

  6. Part B: AUC0-inf of SUZ

    Time frame: Pre-dose up to Day 29

Secondary outcomes

  1. Part A: Cmax of SUZ Metabolite

    Time frame: Pre-dose up to Day 43

  2. Part A: AUC0-tlast of SUZ Metabolite

    Time frame: Pre-dose up to Day 43

  3. Part A: AUC0-inf of SUZ Metabolite

    Time frame: Pre-dose up to Day 43

  4. 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

  5. Part B: Cmax of SUZ Metabolite

    Time frame: Pre-dose up to Day 29

  6. Part B: AUC0-tlast of SUZ Metabolite

    Time frame: Pre-dose up to Day 29

  7. Part B: AUC0-inf of SUZ Metabolite

    Time frame: Pre-dose up to Day 29

  8. Part B: Safety and Tolerability as Assessed by Number of Participants with AEs and SAEs

    Time frame: From Day 1 up to Day 29

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 28, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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