The purpose of the study was to generate cardiac safety data using a supratherapeutic oritavancin dose of 1600 milligrams (mg).
This study was a single-center, double-blind, randomized, placebo-controlled, parallel-design study with an open-label, positive-control moxifloxacin arm to evaluate the effect of supratherapeutic dose of oritavancin on the QT and QT corrected for pulse rate (QTc) intervals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Intravenous oritavancin was administered via 2 dedicated, peripheral venous lines, 1 in each arm. The infusion lasted approximately 3 hours.
Intravenous placebo was administered via 2 dedicated, peripheral venous lines, 1 in each arm. The infusion lasted approximately 3 hours.
Participants randomized to the open-label moxifloxacin treatment arm only received a 400-mg moxifloxacin tablet and did not receive a placebo infusion.
Spaulding Clinical
West Bend, Wisconsin, United States
Placebo-adjusted change from Baseline in QTcF
Placebo-adjusted change from baseline in QTcF (QTc with the Fridericia correction) between each treatment and placebo.
Time frame: predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time
Placebo-adjusted change from baseline in QTcB, HR, RR, PR, and QRS interval analyses.
Placebo-adjusted change from baseline in QTcB, HR, RR, PR, and QRS interval analyses.
Time frame: predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time
Placebo adjusted change from Baseline in the appearance or worsening of ST, T and U-wave morphology.
Placebo adjusted change from baseline in the appearance or worsening of ST, T and U-wave morphology.
Time frame: predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time
Effects on the QTc interval related to plasma concentration levels of oritavancin
Compare the effects on the QTc interval to the plasma levels of oritavancin using concentration-effect modeling
Time frame: predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time
Evaluate the number of volunteers with adverse events or abnormalities in lab/urine results and safety ECGs as measures of safety and tolerability
Compare safety and tolerability in healthy volunteers after a single IV dose of 1600 mg oritavancin
Time frame: Day 0 through Day 7
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