A Study to Evaluate the Effect of Food on the Pharmacokinetics of VX-548

NCT05851157 | Completed Phase 1 FDA Drug

• 1 other identifier: VX22-548-016
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-548 in healthy participants.

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

• Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite

  Pre-dose up to Day 35 Post-dose

• Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of VX-548 and its Metabolite

  Pre-dose up to Day 35 Post-dose

• Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite

  Pre-dose up to Day 35 Post-dose

Secondary Outcomes (1)

• Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From Day 1 up to Day 44

Study Arms (1)

VX-548

EXPERIMENTAL

Participants will be randomized to receive a single dose of VX-548 in 1 of 6 treatment sequences with 3 dosing periods to assess different fed conditions and timing of meal administration on the PK of VX 548. There will be a 14 day washout period between each dosing period.

Drug: VX-548

Interventions

VX-548 DRUG

Tablets for oral administration.

Also known as: Suzetrigine

VX-548

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) of 18.0 to 35.0 kilogram per meter square (Kg/m\^2)
• A total body weight greater than (\>) 50 kilogram (kg)

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
• Participants of childbearing potential

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (1)

ICON Salt Lake City

Salt Lake City, Utah, 84124, 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 9, 2023
• Study Start: May 3, 2023
• Primary Completion: October 30, 2023
• Study Completion: November 8, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)