This study will investigate the effects of therapeutic and supratherapeutic oral doses of CBP-307 on the QTc interval in healthy subjects.
This will be a Phase I, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled, multi-site, 3-arm study to investigate the effects of therapeutic and supratherapeutic oral doses of CBP-307 on the QTc interval in healthy male and female subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
112
CBP-307 capsules oral administration.
Placebo-matched CBP-307 capsules oral administration.
Moxifloxacin tablets oral administration。
Clinical Pharmacology of Miami (CPMI), LLC
Hialeah, Florida, United States
CMAX
Adelaide, South Australia, Australia
Change-from-baseline QT Interval Corrected for Heart Rate Using Fridericia's Method (QTcF)
Change from Baseline in QT interval corrected for heart rate using Fridericia's method (QTcF) to evaluate the effects of therapeutic and supratherapeutic CBP-307 plasma concentrations.
Time frame: From Baseline to Day 16
Change-from-baseline Heart Rate (HR)
Change from Baseline in heart rate (HR).
Time frame: From Baseline at Day 16
Change-from-baseline PR
Change from Baseline in PR.
Time frame: From Baseline at Day 16
Change-from-baseline QRS
Change from Baseline in QRS.
Time frame: From Baseline at Day 16
Placebo-corrected Change-from-baseline HR
Placebo-corrected Change-from-baseline HR based on Change-from-baseline Heart Rate (HR) reported in Outcome Measure 2
Time frame: From Baseline to Day 16
Placebo-corrected Change-from-baseline QTcF
Placebo-corrected change-from-baseline QT Interval Corrected for Heart Rate Using Fridericia's Method (QTcF) based on Change-from-baseline QTcF reported in Outcome Measure 1
Time frame: From Baseline to Day 16
Placebo-corrected Change-from-baseline PR
Placebo-corrected change-from-baseline PR based on Change-from-baseline PR reported in Outcome Measure 3
Time frame: From Baseline to Day 16
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo-matched Moxifloxacin tablets oral administration.
Placebo-corrected Change-from-baseline QRS
Placebo-corrected change-from-baseline QRS based on Change-from-baseline QRS reported in Outcome Measure 4
Time frame: From Baseline to Day 16
Categorical Outliers for QTcF
For categorical outliers, the number (percentage) of subjects as well as timepoints who had increases in absolute QTcF values \>450 and ≤480 msec, \>480 and ≤500 msec, or \>500 msec, and changes from predose baseline of \>30 and ≤60 msec, or \>60 msec.
Time frame: From Baseline to Day 16
Categorical Outliers for HR
For categorical outliers, decrease in HR from predose baseline \>25% to an HR \<50 bpm will be determined.
Time frame: From Baseline to Day 16
Categorical Outliers for PR
For categorical outliers, increase in PR from predose baseline \>25% to a PR \> 200 msec will be determined.
Time frame: From Baseline to Day 16
Categorical Outliers for QRS
For categorical outliers, increase in QRS from predose baseline \>25% to a QRS \>120 msec will be determined.
Time frame: From Baseline to Day 16
Frequency of Treatment-emergent Changes of T-wave Morphology
For T-wave morphology, the analyses will be focused on change from baseline with counts (percentages) for both the number of subjects and the number of timepoints.
Time frame: From Baseline to Day 16
Frequency of Treatment-emergent Changes of U-wave Presence
For U-wave presence, the analyses will be focused on change from baseline with counts (percentages) for both the number of subjects and the number of timepoints.
Time frame: From Baseline to Day 16
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf)
Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) will be analyzed as a pharmacokinetic (PK) parameter.
Time frame: From Baseline to Day 29 ± 2
Area Under the Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC0-24)
Area under the concentration-time curve from time zero to 24 hours postdose (AUC0-24) will be analyzed as a pharmacokinetic (PK) parameter.
Time frame: From Baseline to Day 29 ± 2
Maximum Observed Concentration (Cmax)
Maximum observed concentration (Cmax) will be analyzed as a pharmacokinetic (PK) parameter.
Time frame: From Baseline to Day 29 ± 2
Time of the Maximum Observed Concentration (Tmax)
Time of the maximum observed concentration (tmax) will be analyzed as a pharmacokinetic (PK) parameter.
Time frame: From Baseline to Day 29 ± 2
Incidence and Severity of Adverse Event (AE)
All AEs will be listed and treatment-emergent AEs will be summarized using the descriptive methodology. 14.3.1.1 TEAE
Time frame: From Baseline to Day 29 ± 2