NCT02164812已完成1 期
A Study to Determine the Concentration-Electrocardiographic Effects of Efavirenz in Healthy Subjects Enriched for CYP2B6 Polymorphisms
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Difference from placebo of Efavirenz (EFV) in change from period-specific baseline in the QT interval corrected for heart rate (HR) via Fridericia's method (QTcF) at postdose extraction times (ΔΔQTcF)
研究概览
简要总结
The purpose of this study is to determine whether multiple doses of Efavirenz has an effect on the QTc interval (corrected by Fridericia) in CYP2B6 *1/*6 and *6/*6 healthy subjects.
详细描述
CYP = Cytochrome p-450
Primary Purpose: Other: This is a Phase 1 clinical pharmacology thorough QT study being conducted as a post marketing requirement
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers, ages 18 to 49 years old
- •BMI 18 to 32 kg/m2
- •Women must not be pregnant or breastfeeding
排除标准
- •A personal history of clinically relevant cardiac disease, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
- •History of hypokalemia, personal history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
- •Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration: PR ≥210 msec, QRS ≥120 msec, QT ≥500 msec, QTcF ≥450 msec, HR <45 bpm
- •Second or third degree heart block prior to study drug
- •Positive urine screen for drugs of abuse
- •Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus (HIV)-1, -2 antibody
- •Any of the following lab results outside of the ranges specified below prior to dosing: Alanine aminotransferase (ALT) >upper limit of normal (ULN), aspartate aminotransferase (AST) >ULN, Total bilirubin >ULN, Direct bilirubin >ULN, Creatinine >ULN, Serum potassium <lower limit of normal (LLN), Serum magnesium <LLN
- •History of allergy to Moxifloxacin, Efavirenz or related compounds
研究组 & 干预措施
Moxifloxacin, Placebo, Efavirenz
Experimental
Moxifloxacin, Placebo, Efavirenz single dose as specified
干预措施: Moxifloxacin (Drug)
Moxifloxacin, Placebo, Efavirenz
Experimental
Moxifloxacin, Placebo, Efavirenz single dose as specified
干预措施: Placebo (Drug)
Moxifloxacin, Placebo, Efavirenz
Experimental
Moxifloxacin, Placebo, Efavirenz single dose as specified
干预措施: Efavirenz (Drug)
结局指标
主要结局
Difference from placebo of Efavirenz (EFV) in change from period-specific baseline in the QT interval corrected for heart rate (HR) via Fridericia's method (QTcF) at postdose extraction times (ΔΔQTcF)
时间窗: Days 1, 2, 5, 6, 19 and 20
QTcF = QT corrected for Fridericia's formula
次要结局
- Number and percent of subjects having a maximum QTcF, HR, PR, and QRS outside of pre-specified categories and those having a maximum ΔQTcF outside of pre-specified categories(Days 1, 5 and 19)
- Time of maximum observed plasma concentration (Tmax) of EFV(Days 1, 2, 19 and 20)
- Area under the concentration-time curve in one dosing interval (AUC(TAU)) of EFV(Days 1, 2, 19 and 20)
- Safety based on incidence of AEs, SAEs, AEs leading to discontinuation, marked laboratory abnormalities, findings on 12-lead safety ECG measurements and physical examinations, and abnormalities in vital sign measurements exceeding pre-defined thresholds(Up to 30 days after discontinuation of dose (approximately 52 days))
- Maximum observed plasma concentration (Cmax) of EFV(Days 1, 2, 19 and 20)
- Trough observed plasma concentration 24 h after a dose (C24) of EFV(Days 1, 2, 19 and 20)
- Difference from placebo of Moxifloxacin in change from period-specific baseline in QTcF (ΔΔQTcF) following a single dose(Days 1, 5 and 19)
- Difference from placebo of EFV in change from period-specific baseline in other ECG parameters: HR, PR, QRS, and uncorrected QT following 14 days of dosing(Days 1, 5 and 19)
研究者
研究点 (1)
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