An Electrocardiogram Study to Evaluate the Effect of Vanzacaftor on the QT/QTc Interval in Healthy Participants
Phase 1
Completed
- Conditions
- Cystic Fibrosis
- Interventions
- Registration Number
- NCT05867147
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of this study is to evaluate the effect of Vanzacaftor (VNZ) on QTcF, as well as the pharmacokinetic (PK), safety, and tolerability of VNZ in healthy participants.
- 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
- 56
Inclusion Criteria
- Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (Kg/m^2), both inclusive
- Male and female participants of age 18 to 45 years, both inclusive
- Serum potassium, calcium, and magnesium values within normal ranges
Key
Exclusion Criteria
- Median QTcF>450 msec on triplicate 12-lead ECGs
- History of conduction abnormalities
Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Moxifloxacin Placebo Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and VNZ at different time points. Group 2A Vanzacaftor Placebo Participants will receive VNZ-matching placebo, moxifloxacin, and moxifloxacin-matching placebo at different time points. Group 2A Moxifloxacin Placebo Participants will receive VNZ-matching placebo, moxifloxacin, and moxifloxacin-matching placebo at different time points. Group 2B Vanzacaftor Placebo Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points. Group 1 Vanzacaftor Placebo Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and VNZ at different time points. Group 2B Moxifloxacin Placebo Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and moxifloxacin at different time points. Group 1 Vanzacaftor Participants will receive VNZ-matching placebo, moxifloxacin-matching placebo and VNZ at different time points. Group 2A Moxifloxacin Participants will receive VNZ-matching placebo, moxifloxacin, and moxifloxacin-matching placebo at different time points. Group 2B Moxifloxacin Participants will receive VNZ-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 23
- Secondary Outcome Measures
Name Time Method Change in QRS duration From Baseline up to Day 23 Placebo-corrected Change in QTcF From Baseline up to Day 23 Placebo-corrected Change in HR From Baseline up to Day 23 Placebo-corrected Change in PR interval From Baseline up to Day 23 Placebo-corrected Change in QRS duration From Baseline up to Day 23 Number of Outliers for QTcF From Baseline up to Day 23 Number of Outliers for HR From Baseline up to Day 23 Number of Outliers for PR interval From Baseline up to Day 23 Number of Outliers for QRS duration From Baseline up to Day 23 Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence From Baseline up to Day 23 Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Day -2 up to Day 38 Maximum Observed Plasma Concentration (Cmax) of VNZ Days 11 and 21 Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to 24 hours (AUC0-24h)) of VNZ Days 11 and 21 Time Taken for VNZ to Reach Maximum Concentration (tmax) Days 11 and 21 Change in Heart Rate (HR) From Baseline up to Day 23 Change in PR interval, segment From Baseline up to Day 23
Trial Locations
- Locations (1)
Celerion - Tempe
🇺🇸Tempe, Arizona, United States