A Study to Assess the Cardiac Safety of Oritavancin in Healthy Participants

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.

Inclusion criteria

• Able to give written informed consent before initiation of any study related procedures and willing to comply with all required study procedures.
• Healthy, male and female between 18 and 60 years old, body mass index between 18 and 30 kilograms/meter squared.
• In good health based upon results of medical history, physical examination, no clinically significant 12-lead electrocardiogram (ECG) results, and laboratory test results.
• Serum magnesium and potassium levels within the normal range at Screening.
• Agreed to abstain from alcohol, caffeine-, and xanthine-containing products, all kind of energy drinks and the consumption of grapefruit juice and orange juice from 48 hours before study drug administration until completion of the follow-up visit.

Exclusion criteria

• History of immune-related hypersensitivity reaction to glycopeptides (such as vancomycin, televancin, daptomycin, or teicoplanin) or any of their excipients. Note: participants who had histamine-like infusion reactions to a glycopeptide were not excluded.
• A resting pulse rate < 50 beats per minute (bpm) or > 100 bpm.
• Systolic blood pressure < 90 millimeters of mercury (mmHg) or diastolic blood pressure < 50 mmHg.
• A QTc with the Fridericia correction > 450 microseconds (msec) (males) or > 470 msec (females).
• Respiratory difficulties, or a history of asthma or chronic obstructive pulmonary disease.
• Use of any prescription drug or over-the-counter medications or herbal preparations within 14 days or 5-times the elimination half-life (whichever was longer) prior to starting the study (except for acetaminophen; birth control pills; implantable or injectable birth control; and estrogen, testosterone, and/or progesterone replacement in menopausal women).
• Unwilling to abstain from smoking for the duration of the study.
• Any clinically significant, underlying abnormalities in rhythm, conduction, or morphology of the resting ECG that may have interfered with the interpretation of QTc interval changes.
• Positive result for the urine or serum human chorionic gonadotropin test administered at Screening (females with childbearing potential).
• A past medical history of clinically significant ECG abnormalities or a family history (grandparents, parents, or siblings) of either a long or a short QT syndrome.
• Personal history of unexplained syncope.
• Women who were pregnant or nursing, or who were of childbearing potential and unwilling to use at least 2 acceptable methods of birth control (for example, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, barrier method(s) or male partner sterilization). Women ≥ 2 years postmenopausal or surgically sterile were exempt from this exclusion.
• A history of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents.
• Positive virology screen for human immunodeficiency virus or hepatitis B or C virus, respectively.
• Participated in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of enrollment.
• Any condition, which in the opinion of the Investigator would put the participant at increased risk from participating in the study.