Clinical trial NCT05818852: A Study to Evaluate the Effect of VX-548 on the QT/QTc Interval in Healthy Participants
Official title: A Phase 1, Randomized, Double-blind, Placebo- and Active-controlled, Thorough QT/QTc Study of VX-548 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2023-04-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in QT interval corrected by Fridericia's formula (QTcF)
timeFrame: From Baseline up to Day 12
Secondary outcomes:
measure: Change in Heart Rate (HR)
timeFrame: From Baseline up to Day 12
measure: Change in PR interval, segment
timeFrame: From Baseline up to Day 12
measure: Change in QRS duration
timeFrame: From Baseline up to Day 12
measure: Placebo-corrected Change in QTcF
timeFrame: From Baseline up to Day 12
measure: Placebo-corrected Change in HR
timeFrame: From Baseline up to Day 12
measure: Placebo-corrected Change in PR interval
timeFrame: From Baseline up to Day 12
measure: Placebo-corrected Change in QRS duration
timeFrame: From Baseline up to Day 12
measure: Number of Outliers for QTcF
timeFrame: From Baseline up to Day 12
measure: Number of Outliers for HR
timeFrame: From Baseline up to Day 12
measure: Number of Outliers for PR interval
timeFrame: From Baseline up to Day 12
measure: Number of Outliers for QRS duration
timeFrame: From Baseline up to Day 12
measure: Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence
timeFrame: From Baseline up to Day 12
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 26
measure: Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite
timeFrame: Days 6 and 10: Pre-dose up to 24 hours
measure: Area Under the Concentration versus Time Curve from the time of dosing to 24 hours (AUC0-24h) of VX-548 and its Metabolite
timeFrame: Days 6 and 10: Pre-dose up to 24 hours
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: ICON Lenexa
state: Kansas
city: Salt Lake City
country: United States
facility: ICON Salt Lake City
state: Utah
Study officials:
References: