NCT02182310已完成1 期
Assessment of the Effect of 480 mg and 1200 mg of BI 201335 as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind, Four-way Crossover Phase-I-study With Moxifloxacin as Positive Control
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
- 56
- 主要终点
- QTcI interval (QT interval individually corrected for heart rate)
研究概览
简要总结
To demonstrate that BI 201335 does not prolong the QT interval more than placebo.
To assess the tolerability of 1200 mg of BI 201335 as single dose in female subjects (double-blind, randomised, placebo-controlled) before inclusion of female subjects in the cross-over part of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
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
- •Healthy caucasian males and females, 18 to 50 years of age
- •Body mass index (BMI) ranging from 18.5 to 29.9 kg/m2 (BMI calculation: weight in kilograms divided by the square of height in meters)
- •Signed written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
排除标准
- •Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram (ECG)) deviating from normal and of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- •History of orthostatic hypotension, fainting spells or blackouts
- •Chronic or relevant acute infections
- •History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- •Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug before enrolment in the study or during the study
- •Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
- •Participation in another trial with an investigational drug (≤ 30 days prior to administration or during the trial)
- •Heavy smoker (> 10 cigarettes or > 3 cigars of > 3 pipes/day)
- •Inability to refrain from smoking on trial days
- •Alcohol abuse (> 60 g/day)
- •Drug abuse
- •Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
- •Any deviation of a laboratory value that is considered to be of clinical relevance
- •Excessive physical activities within the last week before the trial or during the trial
- •Hypersensitivity to BI 201335, moxifloxacin or related drugs of these classes
- •Homozygous genotype status for "Gilbert" polymorphisms (Uridine diphosphate (UDP)-glucuronosyl transferase 1A1 (UGT1A1)*28, *60)
- •Heart rate at screening of > 85 bpm or < 40 bpm
- •Any screening ECG value outside of the reference range of clinical relevance including, but not limited to pulse rate (PR) interval > 220 ms, QRS interval > 115 ms, QTcB (QT interval, corrected for heart rate according to Bazett's formula) > 470 ms, or QT (uncorrected) > 470 ms
- •For Female subjects
- •Pregnancy
- •Positive pregnancy test
- •No adequate contraception (adequate contraception e.g. sterilisation, intrauterine pressure , oral contraceptives). Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)
- •Inability to maintain this adequate contraception during the whole study period from the time of screening until one month after the last intake
- •Lactation period
研究组 & 干预措施
BI 201335 placebo
Placebo Comparator
crossover part
干预措施: BI 201335 placebo (Drug)
BI 201335 low dose
Experimental
crossover part
干预措施: BI 201335 low dose (Drug)
BI 201335 high dose
Experimental
crossover part
干预措施: BI 201335 high dose (Drug)
Moxifloxacin
Active Comparator
crossover part
干预措施: Moxifloxacin (Drug)
BI 201335 or Placebo
Experimental
tolerability part in female subjects
干预措施: BI 201335 placebo (Drug)
BI 201335 or Placebo
Experimental
tolerability part in female subjects
干预措施: BI 201335 high dose (Drug)
结局指标
主要结局
QTcI interval (QT interval individually corrected for heart rate)
时间窗: pre-dose and 3 to 8 hours
次要结局
- The change from mean baseline of the QTcI at any point in time between 2 h and 24 h after dosing(Pre dose and 2 to 24 hours post dosing)
- The time-matched changes versus placebo in QTcI at any point in time between 2 h and 24 h after dosing(Pre dose and 2 to 24 hours post dosing)
- The mean value of QTcI changes from baseline between 2 h and 24 h after dosing(Pre dose and 2 to 24 hours post dosing)
研究者
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