A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic Profile and CNS Effects of BIA 2-093, in Young Healthy Male Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 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 investigate the safety and tolerability of multiple dose regimens of BIA 2-093 in healthy young male volunteers
详细描述
Single centre, Phase I, double-blind, randomised, placebo-controlled study investigating 4 multiple rising oral doses of BIA 2-093 in 4 groups of 8 young healthy male subjects. Within each group, 2 subjects were randomised to receive placebo and the remaining 6 subjects to receive BIA 2-093. No subject was a member of more than one group. The dose regimens investigated were: 200 mg b.i.d.(twice daily), 400 mg o.d.(once daily; this was changed from 400 mg b.i.d. in protocol amendment 1, on the basis of interim pharmacokinetic analysis of Group 1 data), 800 mg o.d, and 1200 mg o.d. BIA 2-093/placebo was administered orally once daily on Days 1-8, or twice a day (at 12-hour intervals) on Days 1-7 with a final dose in the morning of Day 8. The multiple dose regimens were to be investigated in ascending order. Progression to each higher dose level was only to occur if the previous dose level was deemed by the investigator and the sponsor to be safe and well tolerated.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult males aged 18-45 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 previous smokers who had not smoked for at least 6 months.
- •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 first 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.
- •Subjects who had previously received BIA 2-093.
研究组 & 干预措施
Group 4 - either 800 mg b.i.d or 1200 mg o.d.
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
干预措施: Placebo (Drug)
Group 1- 200 mg b.i.d. (twice daily)
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
干预措施: Placebo (Drug)
Group 1- 200 mg b.i.d. (twice daily)
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
干预措施: BIA 2-093 (Drug)
Group 2 - 400 mg b.i.d.
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
干预措施: Placebo (Drug)
Group 2 - 400 mg b.i.d.
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
干预措施: BIA 2-093 (Drug)
Group 3- 800 mg o.d. (once daily)
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
干预措施: Placebo (Drug)
Group 3- 800 mg o.d. (once daily)
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
干预措施: BIA 2-093 (Drug)
Group 4 - either 800 mg b.i.d or 1200 mg o.d.
BIA 2-093 200mg with 200 ml potable water. Identical placebo administered as oral tablets.
干预措施: BIA 2-093 (Drug)
结局指标
主要结局
Total Number of Adverse Events
时间窗: up to 20 weeks
Total Number of Adverse Events.
次要结局
- Cmax(Day 1 and Day 8)
- AUC0-τ(Day 1 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, hours post final dose Day 8 - pre-dose, 30, 60, 90, 120, 180 minutes, 4, 6, 7, 8, 12, 24, 36, 48 and 72 hours post final dose)