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.
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.).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Tablets for oral administration.
Capsules for oral administration.
Capsules for oral administration.
ICON Lenexa
Lenexa, Kansas, United States
ICON Salt Lake City
Salt Lake City, Utah, United States
Change in QT interval corrected by Fridericia's formula (QTcF)
Time frame: From Baseline up to Day 12
Change in Heart Rate (HR)
Time frame: From Baseline up to Day 12
Change in PR interval, segment
Time frame: From Baseline up to Day 12
Change in QRS duration
Time frame: From Baseline up to Day 12
Placebo-corrected Change in QTcF
Time frame: From Baseline up to Day 12
Placebo-corrected Change in HR
Time frame: From Baseline up to Day 12
Placebo-corrected Change in PR interval
Time frame: From Baseline up to Day 12
Placebo-corrected Change in QRS duration
Time frame: From Baseline up to Day 12
Number of Outliers for QTcF
Time frame: From Baseline up to Day 12
Number of Outliers for HR
Time frame: From Baseline up to Day 12
Number of Outliers for PR interval
Time frame: From Baseline up to Day 12
Number of Outliers for QRS duration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tablets for oral administration.
Time frame: From Baseline up to Day 12
Frequency of Treatment-emergent Changes of T-wave Morphology and U-wave Presence
Time frame: From Baseline up to Day 12
Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to Day 26
Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite
Time frame: 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
Time frame: Days 6 and 10: Pre-dose up to 24 hours