A Study to Evaluate the Effect of VX-548 on the QT/QTc Interval in Healthy Participants

NCT05818852 | Completed Phase 1 FDA Drug

• 1 other identifier: VX21-548-009
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to evaluate the effects of clinical and high clinical exposures of VX-548 and its metabolite on QTcF, and the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VX-548 and its metabolite.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Change in QT interval corrected by Fridericia's formula (QTcF)

  From Baseline up to Day 12

Secondary Outcomes (15)

• Change in Heart Rate (HR)

  From Baseline up to Day 12

• Change in PR interval, segment

  From Baseline up to Day 12

• Change in QRS duration

  From Baseline up to Day 12

• Placebo-corrected Change in QTcF

  From Baseline up to Day 12

• Placebo-corrected Change in HR

  From Baseline up to Day 12

Study Arms (3)

Group 1

EXPERIMENTAL

Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and VX-548 at different time points.

Drug: VX-548; Drug: Moxifloxacin Placebo; Drug: VX-548 Placebo

Group 2A

ACTIVE COMPARATOR

Participants will receive VX-548-matching placebo, moxifloxacin and moxifloxacin-matching placebo at different time points.

Drug: Moxifloxacin; Drug: Moxifloxacin Placebo; Drug: VX-548 Placebo

Group 2B

ACTIVE COMPARATOR

Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points.

Drug: Moxifloxacin; Drug: Moxifloxacin Placebo; Drug: VX-548 Placebo

Interventions

VX-548 DRUG

Tablets for oral administration.

Also known as: Suzetrigine

Group 1

Moxifloxacin DRUG

Capsules for oral administration.

Group 2A; Group 2B

Moxifloxacin Placebo DRUG

Capsules for oral administration.

Group 1; Group 2A; Group 2B

VX-548 Placebo DRUG

Tablets for oral administration.

Group 1; Group 2A; Group 2B

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)

You may not qualify if:

• History of febrile illness within 5 days before the first dose of study drug
• Any condition possibly affecting drug absorption
• Known hypersensitivity or prior adverse reaction to moxifloxacin or other quinolones

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (2)

ICON Lenexa

Lenexa, Kansas, 66219, United States

Location

ICON Salt Lake City

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: April 19, 2023
• Study Start: April 12, 2023
• Primary Completion: June 12, 2023
• Study Completion: June 28, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)