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

Study Overview
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Brief Summary
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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
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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.).

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

Conditions
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Pain

Intervention / Treatment
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* Drug: VX-548
* Drug: Moxifloxacin
* Drug: Moxifloxacin Placebo
* Drug: VX-548 Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |