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

Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336096
• Other study ID #: VX23-548-017
• Status: Recruiting
• Phase: Phase 1
• Start date: March 28, 2024
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: Vertex Pharmaceuticals Incorporated
• Contact: Medical Information
• Phone: 617-341-6777
• Email: medicalinfo[@]vrtx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Suzetrigine
Tablet(s) for oral administration.
• Suzetrigine
Tablet(s) and Suspension for oral administration.

Locations

Country	Name	City	State
United States	Celerion - Tempe	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Maximum Observed Plasma Concentration (Cmax) of SUZ		Pre-dose up to Day 43
Primary	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
Primary	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
Primary	Part B: Cmax of SUZ		Pre-dose up to Day 29
Primary	Part B: AUC0-tlast of SUZ		Pre-dose up to Day 29
Primary	Part B: AUC0-inf of SUZ		Pre-dose up to Day 29
Secondary	Part A: Cmax of SUZ Metabolite		Pre-dose up to Day 43
Secondary	Part A: AUC0-tlast of SUZ Metabolite		Pre-dose up to Day 43
Secondary	Part A: AUC0-inf of SUZ Metabolite		Pre-dose up to Day 43
Secondary	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
Secondary	Part B: Cmax of SUZ Metabolite		Pre-dose up to Day 29
Secondary	Part B: AUC0-tlast of SUZ Metabolite		Pre-dose up to Day 29
Secondary	Part B: AUC0-inf of SUZ Metabolite		Pre-dose up to Day 29
Secondary	Part B: Safety and Tolerability as Assessed by Number of Participants with AEs and SAEs		From Day 1 up to Day 29
Secondary	Part C: Cmax of SUZ and its Metabolite		Pre-dose up to Day 29
Secondary	Part C: AUC0-tlast of SUZ and its Metabolite		Pre-dose up to Day 29
Secondary	Part C: AUC0-inf of SUZ and its Metabolite		Pre-dose up to Day 29
Secondary	Part C: Safety and Tolerability as Assessed by Number of Participants with AEs and SAEs		From Day 1 up to Day 29