A Phase I Thorough QT/QTc Study To Evaluate The Effect of Therapeutic and Supratherapeutic Multiple Doses of Prucalopride on Cardiac Repolarisation in Healthy Male and Female Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- Treatment with therapeutic (2 mg) or supratherapeutic (10 mg) doses of prucalopride in healthy male and female volunteers does not increase QTc interval compared to placebo.
研究概览
简要总结
This is a 2-arm, parallel-group active- and placebo-controlled, double-blind randomised study, stratified by gender and with a hybrid crossover group design, to compare treatment with prucalopride 2 mg/day (intended therapeutic dose) and prucalopride 10 mg/day (supratherapeutic dose) with placebo. A single oral dose of 400 mg moxifloxacin is included as a positive control in terms of the effect on cardiac repolarisation.
Study hypothesis:
Treatment with therapeutic (2 mg) or supratherapeutic (10 mg) doses of prucalopride in healthy male and female volunteers will not increase QTc interval compared to placebo.
详细描述
A total number of 120 healthy subjects (with an approximate 1:1 female:male ratio) are planned to be randomised.
Day 1: a baseline ECG profile. Day 1: Group 1 will receive prucalopride, Group 2a will receive moxifloxacin, and Group 2b will receive placebo.
On Day 5 (steady-state level is reached), a full ECG assessment day will be performed, enabling the comparison of prucalopride 2 mg with placebo.
Subsequently, the number of tablets will be escalated in all groups (blinded) with 1 tablet a day up to 5 tablets.
On Day 13 (steady state for the supratherapeutic dose level of 10 mg of prucalopride) another ECG assessment day will be performed, enabling a comparison of prucalopride 10 mg with placebo.
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
- Double (Participant, Investigator)
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 volunteers aged between 18 to 50 years.
- •Body mass index (BMI) between 18 and 30 kg/m
- •Female subjects must:
- •be of childbearing potential with a negative serum β-human chorionic gonadotropin (β-HCG) test at screening, and be willing and able to use medically acceptable double barrier methods of birth control, throughout the whole study; or
- •be postmenopausal; or
- •have received surgical sterilisation at least 6 months before screening; AND
- •females must not be receiving hormone replacement therapy (HRT).
- •Main exclusion Criteria:
- •Abnormal QTcF and/or heart rate/blood pressure values at baseline.
- •Subjects with ECG abnormalities that may interfere with the accurate assessment of the QT interval.
- •Subjects with known cardiovascular disorders.
- •Subjects with known clinically significant arrhythmias.
- •Subjects with risk factors e.g., Torsades de Pointes.
- •Subjects with clinically relevant, abnormal serum electrolytes or complete blood count (CBC) at screening.
- •Female subjects who are lactating or pregnant.
- •Subjects suffering from other significant medical conditions.
- •Subjects with a known allergy or sensitivity to moxifloxacin, or to prucalopride.
- •Subjects with a positive screening test for hepatitis B, hepatitis C, or HIV at screening.
排除标准
- 未提供
研究组 & 干预措施
1
Prucalopride
干预措施: prucalopride (Drug)
2
Placebo/moxifloxacin
干预措施: moxifloxacin (Drug)
2
Placebo/moxifloxacin
干预措施: placebo (Drug)
结局指标
主要结局
Treatment with therapeutic (2 mg) or supratherapeutic (10 mg) doses of prucalopride in healthy male and female volunteers does not increase QTc interval compared to placebo.
时间窗: January to April 2009
次要结局
未报告次要终点