NCT02243241已完成1 期
A Randomized, Double-blind, Placebo- and Positive-Controlled, Parallel Group, Dose Escalating Study of the Effect of Hydrocodone Bitartrate (HYD) Extended-Release Tablets at Doses up to 160 mg on QT/QTc in Healthy Adult Subjects
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
- 208
- 试验地点
- 1
- 主要终点
- The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method
研究概览
简要总结
Evaluate the effect of multiple doses (once daily for 3 days each of HYD 80, 120, and 160 mg tablets) on the QT/QTc interval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide written informed consent;
- •Body weight ranging from 50 to 100 kilograms (kg) [110 to 220 pounds] and body mass index (BMI) of 18 to 30 (kg/m2);
- •Males and females aged 18 to 50 years;
- •Willing to eat the food supplied during the study;
- •Willing to refrain from strenuous exercise through the end-of-study visit. Subjects did not begin a new exercise program nor participate in any unusually strenuous physical exertion;
- •Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and safety 12-lead ECG;
- •Females of childbearing potential must use an adequate and reliable method of contraception (ie, barrier with additional spermicidal foam or jelly, intra-uterine device, hormonal contraception). Females who are postmenopausal must be postmenopausal for ≥ 1 year and have elevated serum follicle stimulating hormone (FSH).
排除标准
- •Females who are pregnant (positive beta human chorionic gonadotropin test) or lactating;
- •Current or recent (within 5 years) history of drug or alcohol abuse;
- •History or any current conditions that may interfere with drug absorption, distribution, metabolism, or excretion;
- •Use of an opioid-containing medication in the past 30 days preceding the initial dose in this study;
- •Known allergy to hydrocodone, opioids, psychotropic or hypnotic drugs, moxifloxacin, or any member of the quinolone class drugs;
- •Any history of frequent nausea or emesis regardless of etiology;
- •Any history of seizures or head trauma with sequelae;
- •Participation in a clinical drug study during the 30 days preceding the initial dose of study drug in this study;
- •Use of any medication including thyroid hormonal therapy (hormonal contraception and hormonal replacement therapy in the form of estrogen with or without progestin is allowed), vitamins, herbal and/or mineral supplements during the 7 days preceding the initial dose of study drug;
- •Any significant illness during the 30 days preceding the initial dose of study drug in this study;
- •Any personal or family history of prolonged QT interval or disorders of cardiac rhythm;
- •Abnormal cardiac conditions including hypertension;
- •Abnormal cardiac condition denoted by any of the following:
- •QT data corrected for heart rate using the Fridericia formula (QTcF) interval >450 milliseconds (msec)
- •PR interval >240 msec or QRS >110 msec
- •Evidence of second- or third-degree atrioventricular block
- •Pathological Q-waves (defined as Q-wave >40 msec or depth >0.5 millivolts [mV])
- •Evidence of ventricular pre-excitation, complete left bundle branch block (LBBB), right bundle branch block (RBBB), or incomplete RBBB
- •With a resting heart rate (HR) outside the range of 40 to 90 beats per minute (bpm);
- •Abnormalities on physical examination, vital signs, safety 12-lead ECG, or clinical laboratory values, unless those abnormalities are judged clinically insignificant by the investigator;
- •Oxygen saturation <94% as measured by pulse oximetry (SpO2);
- •Refusal to abstain completely from caffeine or xanthine during confinement;
- •Refusal to abstain from consumption of alcoholic beverages 48 hours prior to initial study drug administration through the end-of-study visit;
- •Blood or blood products donated within 30 days prior to initial study drug administration or any time through the end-of-study visit, except as required by the study protocol;
- •History of smoking or use of nicotine products within 45 days of initial study drug administration or a positive urine cotinine test;
- •Positive results of urine drug screen or alcohol screen;
- •Positive results of hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV);
- •Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities;
- •The investigator believes the subject to be unsuitable for reason(s) not specifically stated in the exclusion criteria.
研究组 & 干预措施
HYD
Experimental
干预措施: HYD (Drug)
HYD
Experimental
干预措施: Placebo for moxifloxacin (Drug)
Moxifloxacin
Other
Moxifloxacin is the positive control.
干预措施: Moxifloxacin (Drug)
Moxifloxacin
Other
Moxifloxacin is the positive control.
干预措施: Placebo for HYD (Drug)
Placebo
Placebo Comparator
Placebo for HYD and placebo for moxifloxacin
干预措施: Placebo for HYD (Drug)
Placebo
Placebo Comparator
Placebo for HYD and placebo for moxifloxacin
干预措施: Placebo for moxifloxacin (Drug)
结局指标
主要结局
The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method
时间窗: Baseline and Day 15
The ECG effects of HYD 160 mg (day 15) on the QT/QTc interval
次要结局
- The time-matched analysis on QT data (change from baseline, placebo-subtracted) corrected for heart rate (QTc), based on an individual correction (QTcI) method(Baseline and Day 15)
研究者
研究点 (1)
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