NCT00488215已完成1 期
A Double-Blind, Placebo-Controlled, 2-Way Cross-Over Trial in Healthy Volunteers, to Evaluate the Pharmacokinetics, Tolerability and Cardiac Safety of Oral Prucalopride at Steady State, After up-Titration to a Maximum of 20 mg.
Movetis0 个研究点目标入组 32 人开始时间: 2000年1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
- 32
- 主要终点
- The exploration whether the maximum tolerable dose (MTD, defined as the highest dose not causing severe drug-related adverse events in > 50 % of the subjects) is achieved between 0 and 20 mg prucalopride.
研究概览
简要总结
An escalating dose of prucalopride up to a maximum of 20 mg was given once daily to 32 healthy volunteers to determine safety at the maximum tolerable dose or at 20 mg.
详细描述
This is a single-centre, double-blind, placebo-controlled, cross-over trial in 32 healthy volunteers with two sessions (I and II). Each session consists of a run-in day for baseline assessments, 13 treatment days and 5 additional days for assessments. Subjects will be randomized to start with either the prucalopride or placebo session.
Between the 2 sessions, there will be a washout period of 14 to 21 days, to avoid any carry-over effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 45 years, extremes included.
- •Subject has a normal weight as defined by a Quetelet Index range of 18 - 30 kg/m2, extremes included.
- •Informed consent form signed and dated, prior to screening.
- •Healthy on the basis of a pre-trial physical examination, medical history, anamnesis, electrocardiogram, 24 hour Holter monitoring and the results of blood biochemistry and haematology tests and a urinalysis carried out in 3 weeks preceding randomization.
排除标准
- •History or suspicion of alcohol, barbiturate, amphetamine or narcotic abuse.
- •Smoking more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 6 months prior to selection.
- •History of cardiac arrhythmia's, bronchospastic or cardiovascular disease (e.g. ischemic heart disease or cerebrovascular accident), diabetes mellitus, thyrotoxicosis, Parkinsonism, drug allergy.
- •Presence of prolonged QTc (Bazett) on ECG at screening (QTc > 450 msec in male subjects, QTc > 470 msec in female subjects).
- •Use of concomitant medication, except for oral contraceptives and paracetamol. All other medication must have been stopped at least 14 days before the first dose.
- •Participation in an investigational drug trial in 30 days prior to the first visit.
- •Donation of blood in the 60 days preceding the first visit.
- •Pregnancy (as confirmed by a HCG test during screening and at day 0 of each treatment session) or breast-feeding female.
- •Subjects with positive results for HIV, hepatitis B or C at screening.
- •Female subjects of childbearing potential without adequate contraceptive protection during the trial.
研究组 & 干预措施
1
Active Comparator
Prucalopride
干预措施: prucalopride (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
The exploration whether the maximum tolerable dose (MTD, defined as the highest dose not causing severe drug-related adverse events in > 50 % of the subjects) is achieved between 0 and 20 mg prucalopride.
时间窗: 26 days
次要结局
- The documentation of laboratory and cardiovascular safety (vital signs, ECG, Holter monitoring) at the MTD or at 20 mg.(26 days)
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