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

A Phase 1, Randomized, Double-blind, Placebo- and Active-controlled, Thorough QT/QTc Study of VX-548 in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: VX-548; Drug: Moxifloxacin Placebo; Drug: VX-548 Placebo; Drug: Moxifloxacin

Detailed 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.).

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • ICON Lenexa
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • ICON Salt Lake City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Key Exclusion Criteria:

• 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

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and VX-548 at different time points.	Drug: VX-548; Tablets for oral administration.; Other Names: Suzetrigine; Drug: Moxifloxacin Placebo; Capsules for oral administration.; Drug: VX-548 Placebo; Tablets for oral administration.
Active Comparator: Group 2A; Participants will receive VX-548-matching placebo, moxifloxacin and moxifloxacin-matching placebo at different time points.	Drug: Moxifloxacin Placebo; Capsules for oral administration.; Drug: VX-548 Placebo; Tablets for oral administration.; Drug: Moxifloxacin; Capsules for oral administration.
Active Comparator: Group 2B; Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points.	Drug: Moxifloxacin Placebo; Capsules for oral administration.; Drug: VX-548 Placebo; Tablets for oral administration.; Drug: Moxifloxacin; Capsules for oral administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in QT interval corrected by Fridericia's formula (QTcF)	From Baseline up to Day 12

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Placebo-corrected Change in PR interval	From Baseline up to Day 12
Placebo-corrected Change in QRS duration	From Baseline up to Day 12
Number of Outliers for QTcF	From Baseline up to Day 12
Number of Outliers for HR	From Baseline up to Day 12
Number of Outliers for PR interval	From Baseline up to Day 12
Number of Outliers for QRS duration	From Baseline up to Day 12
Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence	From Baseline up to Day 12
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	From Day 1 up to Day 26
Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite	Days 6 and 10: Pre-dose up to 24 hours
Area Under the Concentration versus Time Curve from the time of dosing to 24 hours (AUC0-24h) of VX-548 and its Metabolite	Days 6 and 10: Pre-dose up to 24 hours

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2023
• Primary Completion (Actual): June 12, 2023
• Study Completion (Actual): June 28, 2023

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
• Other Study ID Numbers: VX21-548-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No