NCT01762839已完成1 期
A Double-Blind, Randomized, Placebo-Controlled, Parallel-Design, Study With an Open-Label Positive-Control, to Assess the Cardiac Safety of Oritavancin in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Placebo-adjusted change from Baseline in QTcF
研究概览
简要总结
The purpose of the study was to generate cardiac safety data using a supratherapeutic oritavancin dose of 1600 milligrams (mg).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Oritavancin
Experimental
Single-dose intravenous (IV) oritavancin diphosphate
干预措施: Single-Dose IV Oritavancin Diphosphate (Drug)
Placebo
Placebo Comparator
Single-dose IV placebo
干预措施: Placebo (Drug)
Moxifloxacin
Active Comparator
Moxifloxacin tablet
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Placebo-adjusted change from Baseline in QTcF
时间窗: predose, 3,3.5,4,5,6,7,9,11,15,24 hours post infusion start time
Placebo-adjusted change from baseline in QTcF (QTc with the Fridericia correction) between each treatment and placebo.
次要结局
- Placebo-adjusted change from baseline in QTcB, HR, RR, PR, and QRS interval analyses.(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.(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(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(Day 0 through Day 7)
研究者
研究点 (1)
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