A Study to Evaluate the Effect of VX-548 on the QT/QTc Interval in Healthy Participants
Phase 1
Completed
- Conditions
- Pain
- Interventions
- Registration Number
- NCT05818852
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- 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.).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 VX-548 Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and VX-548 at different time points. Group 2B Moxifloxacin Placebo Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points. Group 1 Moxifloxacin Placebo Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and VX-548 at different time points. Group 1 VX-548 Placebo Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and VX-548 at different time points. Group 2A Moxifloxacin Placebo Participants will receive VX-548-matching placebo, moxifloxacin and moxifloxacin-matching placebo at different time points. Group 2A VX-548 Placebo Participants will receive VX-548-matching placebo, moxifloxacin and moxifloxacin-matching placebo at different time points. Group 2B VX-548 Placebo Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points. Group 2A Moxifloxacin Participants will receive VX-548-matching placebo, moxifloxacin and moxifloxacin-matching placebo at different time points. Group 2B Moxifloxacin Participants will receive VX-548-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points.
- Primary Outcome Measures
Name Time Method Change in QT interval corrected by Fridericia's formula (QTcF) From Baseline up to Day 12
- Secondary Outcome Measures
Name Time Method Change in QRS duration From Baseline up to Day 12 Change in Heart Rate (HR) From Baseline up to Day 12 Change in PR interval, segment 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 PR interval From Baseline up to Day 12 Number of Outliers for 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 Number of Outliers for QTcF From Baseline up to Day 12 Number of Outliers for HR 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
Trial Locations
- Locations (2)
ICON Lenexa
🇺🇸Lenexa, Kansas, United States
ICON Salt Lake City
🇺🇸Salt Lake City, Utah, United States