A Single Centre, Phase I, Double-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetic Profile and Effects on EEG of Single Rising Oral Doses of BIA 2-093 When Given to Healthy Male Adult Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Total Number of Adverse Events
研究概览
简要总结
The purpose of this study is to determine the safety and tolerability of single rising oral doses of BIA 2-093 (proposed doses 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg) in groups of 8 healthy male adult volunteers.
详细描述
Single centre, Phase I, double-blind, randomised, placebo-controlled study to investigate single rising oral doses of BIA 2-093 up to 1200 mg in sequential groups of eight healthy male adult subjects. Within each group of eight subjects two subjects were randomised to receive placebo and the remaining six subjects were randomised to receive BIA 2-093. No subject was a member of more than one treatment group. Doses of 20mg, 50mg, 100mg, 200mg, 400mg, 600mg, 900mg and 1200mg were investigated in ascending order. Progression to each dose occurred only after the previous dose level was deemed to be safe and well tolerated by the investigator and the sponsor.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult males aged 18-35 years, with a body mass index (BMI) of 19-28 kg/m
- •Subjects who were healthy as determined by pre-study medical history, physical examination, 12-lead ECG and EEG.
- •Subjects who had clinical laboratory tests acceptable to the investigator.
- •Subjects who were negative for HbsAg, anti-HCV and HIV I and II tests at screening.
- •Subjects who were negative for drugs of abuse and alcohol tests at screening and admission.
- •Subjects who were non-smokers or who smoked less than 10 cigarettes (or equivalent) per day.
- •Subjects who were able and willing to give written informed consent.
排除标准
- •Subjects who did not conform to the above inclusion criteria.
- •Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.
- •Subjects who had a clinically relevant surgical history.
- •Subjects who had a clinically relevant family history.
- •Subjects who had a history of relevant atopy.
- •Subjects who had a history of relevant drug hypersensitivity (carbamazepine and related compounds)
- •Subjects who had a history of alcoholism.
- •Subjects who had a history of drug abuse.
- •Subjects who consumed more than 28 units of alcohol a week.
- •Subjects who had a significant infection or known inflammatory process on screening and/or admission
- •Subjects who had acute gastrointestinal symptoms at the time of screening and/or admission (e.g. nausea, vomiting, diarrhoea, heartburn).
- •Subjects who had an acute infection such as influenza at the time of screening and/or admission.
- •Subjects who had used prescription drugs within 4 weeks of dosing.
- •Subjects who had used over the counter medication, excluding routine vitamins but including mega dose vitamin therapy, within one week of dosing.
- •Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of admission to this study.
- •Subjects who had donated and/or received any blood or blood products within 3 months prior to screening.
- •Subjects who were vegetarians, vegans and/or had medical dietary restrictions.
- •Subjects who could not communicate reliably with the investigator.
- •Subjects who were unlikely to co-operate with the requirements of the study.
- •Subjects who were unwilling or unable to give written informed consent.
研究组 & 干预措施
Group 7 (900 mg)
干预措施: Placebo (Drug)
Group 1 (20 mg)
干预措施: BIA 2-093 (Drug)
Group 1 (20 mg)
干预措施: Placebo (Drug)
Group 2 (50 mg)
干预措施: BIA 2-093 (Drug)
Group 2 (50 mg)
干预措施: Placebo (Drug)
Group 3 (100 mg)
干预措施: BIA 2-093 (Drug)
Group 3 (100 mg)
干预措施: Placebo (Drug)
Group 4 (200 mg)
干预措施: BIA 2-093 (Drug)
Group 4 (200 mg)
干预措施: Placebo (Drug)
Group 5 (400 mg)
干预措施: BIA 2-093 (Drug)
Group 5 (400 mg)
干预措施: Placebo (Drug)
Group 6 (600 mg)
干预措施: BIA 2-093 (Drug)
Group 6 (600 mg)
干预措施: Placebo (Drug)
Group 7 (900 mg)
干预措施: BIA 2-093 (Drug)
Group 8 (1200 mg)
干预措施: BIA 2-093 (Drug)
Group 8 (1200 mg)
干预措施: Placebo (Drug)
结局指标
主要结局
Total Number of Adverse Events
时间窗: up to 20 weeks
An adverse event was defined as any undesirable event occurring to a subject during the study, whether or not related to the investigational product
次要结局
未报告次要终点