The purpose of this study is to assess the effects on placebo-corrected change from baseline QT interval corrected for individual heart rate (QTcI) of JNJ-64565111 close to steady state on Day 26 and on electrocardiogram morphology at supratherapeutic exposures in otherwise healthy overweight/obese adults after 4 weeks of treatment with JNJ 64565111 administered subcutaneously once weekly.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
188
Participants will receive JNJ-64565111, subcutaneously on days 2, 9, 16, and 23.
Participants will receive moxifloxacin capsule on days 1 or 27 in a nested crossover manner.
Participants will receive JNJ-64565111-matching Placebo vehicle solution subcutaneously on days 2, 9, 16, and 23.
Participants will receive moxifloxacin-matching placebo capsule on days 1 and 27 in treatment group 1 and on day 1 or 27 in treatment group 2.
Celerion
Tempe, Arizona, United States
Placebo-Corrected Change from Baseline in QT Interval Corrected for Individual Heart Rate (QTcI) on Day 26 Time-Matched Time Points
Placebo-corrected change from baseline in QT interval corrected for individual heart rate (QTcI) on day 26 time-matched time points will be determined. The mean change from baseline in QTcI for participants who receive placebo will be subtracted from the mean change from baseline in QTcI for participants on JNJ-64565111 at the same time point to generate placebo-corrected change from baseline in QTcI, which will be presented.
Time frame: Baseline and Day 26
Change from Time-Matched Baseline in QTc Interval
The QT interval corrected for heart rate (QTc interval) using Fridericia method will be measured by electrocardiograms (ECG).
Time frame: Up to Day 27
Change from Time-Matched Baseline in Heart Rate (HR)
The HR will be measured by ECG.
Time frame: Up to Day 27
Change from Time-Matched Baseline in QRS Interval
The QRS Intervals will be measured by ECG.
Time frame: Up to Day 27
Change from Time-Matched Baseline in PR Interval
The PR intervals will be measured by ECG.
Time frame: Up to Day 27
Cardiac Repolarization as Determined by Mean Change from Time-Matched Baseline in QT Interval Corrected for Individual HR (QTcI) on Day 5
Mean change from time-matched baseline in QT interval corrected for individual HR (QTcI) on day 5 to determine the effect of JNJ-64565111 on cardiac repolarization.
Time frame: Baseline and Day 5
Cardiac Repolarization as Determined by Mean Change from Time-Matched Baseline in QT Interval Corrected For HR Using Fridericia's Formula (QTcF) on Day 5 and Day 26
Mean change from time-matched baseline in QT interval corrected for HR using Fridericia's formula (QTcF) will be assessed on day 5 and day 26 to determine the effect of JNJ-64565111 on cardiac repolarization.
Time frame: Baseline, Day 5 and Day 26
Maximum Observed Serum Concentration (Cmax)
Cmax is defined as the maximum observed serum analyte concentration.
Time frame: Days 1, 5, 26 and 27
Time to Reach Maximum Observed Serum Concentration (Tmax)
Tmax is defined as actual sampling time to reach maximum observed serum analyte concentration.
Time frame: Days 1, 5, 26 and 27
Average Serum Analyte Concentration (Cavg)
Cavg is defined as average serum analyte concentration.
Time frame: Days 1, 5, 26 and 27
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Time frame: From signing of the informed consent form (ICF) to end of study (approximately 12 weeks)
QTcI Changes Evaluated Using ECG Assessments versus Serum Concentrations of JNJ-64565111
QTcI changes evaluated using ECG assessments versus serum concentrations of JNJ-64565111 will be quantified. QTcI is a QT interval corrected for heart rate using individual-specific correction formula and QTcI changes will be quantified using a linear or nonlinear mixed effects modeling approach.
Time frame: Up to Day 27
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