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Completed

NCT Number: NCT05818852

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

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.

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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

ICON Lenexa, Lenexa, Kansas, United States

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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)

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.

Treatment and study plan

VX-548

Drug

Tablets for oral administration.

Other names: Suzetrigine

moxifloxacin

Drug

Capsules for oral administration.

Moxifloxacin Placebo

Drug

Capsules for oral administration.

VX-548 Placebo

Drug

Tablets for oral administration.

Primary outcomes

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

    Time frame: From Baseline up to Day 12

Secondary outcomes

  1. Change in Heart Rate (HR)

    Time frame: From Baseline up to Day 12

  2. Change in PR interval, segment

    Time frame: From Baseline up to Day 12

  3. Change in QRS duration

    Time frame: From Baseline up to Day 12

  4. Placebo-corrected Change in QTcF

    Time frame: From Baseline up to Day 12

  5. Placebo-corrected Change in HR

    Time frame: From Baseline up to Day 12

  6. Placebo-corrected Change in PR interval

    Time frame: From Baseline up to Day 12

  7. Placebo-corrected Change in QRS duration

    Time frame: From Baseline up to Day 12

  8. Number of Outliers for QTcF

    Time frame: From Baseline up to Day 12

  9. Number of Outliers for HR

    Time frame: From Baseline up to Day 12

  10. Number of Outliers for PR interval

    Time frame: From Baseline up to Day 12

  11. Number of Outliers for QRS duration

    Time frame: From Baseline up to Day 12

  12. Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence

    Time frame: From Baseline up to Day 12

  13. 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 26

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

    Time frame: Days 6 and 10: Pre-dose up to 24 hours

  15. Area Under the Concentration versus Time Curve from the time of dosing to 24 hours (AUC0-24h) of VX-548 and its Metabolite

    Time frame: Days 6 and 10: Pre-dose up to 24 hours

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2023
Registry last updated
Mar 20, 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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