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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05818852
• Other study ID #: VX21-548-009
• Status: Completed
• Phase: Phase 1
• Start date: April 12, 2023
• Est. completion date: June 28, 2023

Study information

• Verified date: March 2024
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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: Completed
• Enrollment: 72
• Est. completion date: June 28, 2023
• Est. primary completion date: June 12, 2023
• 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)

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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• VX-548
Tablets for oral administration.
• Moxifloxacin
Capsules for oral administration.
• Moxifloxacin Placebo
Capsules for oral administration.
• VX-548 Placebo
Tablets for oral administration.

Locations

Country	Name	City	State
United States	ICON Lenexa	Lenexa	Kansas
United States	ICON Salt Lake City	Salt Lake City	Utah

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	Change in QT interval corrected by Fridericia's formula (QTcF)		From Baseline up to Day 12
Secondary	Change in Heart Rate (HR)		From Baseline up to Day 12
Secondary	Change in PR interval, segment		From Baseline up to Day 12
Secondary	Change in QRS duration		From Baseline up to Day 12
Secondary	Placebo-corrected Change in QTcF		From Baseline up to Day 12
Secondary	Placebo-corrected Change in HR		From Baseline up to Day 12
Secondary	Placebo-corrected Change in PR interval		From Baseline up to Day 12
Secondary	Placebo-corrected Change in QRS duration		From Baseline up to Day 12
Secondary	Number of Outliers for QTcF		From Baseline up to Day 12
Secondary	Number of Outliers for HR		From Baseline up to Day 12
Secondary	Number of Outliers for PR interval		From Baseline up to Day 12
Secondary	Number of Outliers for QRS duration		From Baseline up to Day 12
Secondary	Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence		From Baseline up to Day 12
Secondary	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
Secondary	Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite		Days 6 and 10: Pre-dose up to 24 hours
Secondary	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