Double-Blind, Randomised, Placebo-Controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202, in Young Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax) - D1
研究概览
简要总结
The objectives as stated in the study protocol were as follows:
- To investigate the safety and tolerability of three multiple dose regimens of BIA 3-202 (50 mg twice a day, 100 mg twice a day and 200 mg twice a day in healthy young male volunteers). Part A
- To characterise the steady state pharmacokinetic and pharmacodynamic profile of BIA 3-202 in healthy young males. Part A
- To investigate the safety and tolerability of a single multiple dose regimen (dose to be determined from Part A) of BIA 3-202, in healthy elderly volunteers. Part B
- To characterise the steady state pharmacokinetic and pharmacodynamic profile of a single multiple dose regimen (dose to be determined from Part A) of BIA 3- 202 in healthy elderly volunteers. Part B
详细描述
This was designed as a single centre, phase I, double-blind, randomised, placebocontrolled study of three multiple rising doses in three sequential groups of 8 young male healthy volunteers (Part A) and a single group of healthy elderly volunteers (Part B).
In Part B, 12 healthy elderly volunteers were to be enrolled. Ten were to be randomly allocated to BIA 3-202 and two to 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 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 and 12-lead ECG.
- •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.
- •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 first dosing.
- •Subjects who had used any investigational drug and/or participated in any clinical trial within 3 months of their first admission to this study.
- •Subjects who had previously received BIA 3-
- •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 1: BIA 3-202 50 mg/placebo
Group 1: BIA 3-202 50 mg/placebo on Day 1; BIA 3-202 50 mg/placebo b.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 50 mg/placebo on Day 9.
50 mg BIA 3-202: 5 x 10 mg BIA 3-202 tablets
干预措施: BIA 3-202 (Drug)
Group 1: BIA 3-202 50 mg/placebo
Group 1: BIA 3-202 50 mg/placebo on Day 1; BIA 3-202 50 mg/placebo b.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 50 mg/placebo on Day 9.
50 mg BIA 3-202: 5 x 10 mg BIA 3-202 tablets
干预措施: Placebo (Drug)
Group 2: BIA 3-202 100 mg/placebo
Group 2: BIA 3-202 100 mg/placebo on Day 1; BIA 3-202 100 mg/placebo b.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 100 mg/placebo on Day 9.
100 mg BIA 3-202: 1 x 100 mg BIA 3-202 tablet
干预措施: BIA 3-202 (Drug)
Group 2: BIA 3-202 100 mg/placebo
Group 2: BIA 3-202 100 mg/placebo on Day 1; BIA 3-202 100 mg/placebo b.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 100 mg/placebo on Day 9.
100 mg BIA 3-202: 1 x 100 mg BIA 3-202 tablet
干预措施: Placebo (Drug)
Group 3: BIA 3-202 200 mg/placebo
Group 3: BIA 3-202 200 mg/placebo on Day 1; BIA 3-202 200 mg/placebo b.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 200 mg/placebo on Day 9.
200 mg BIA 3-202: 2 x 100 mg BIA 3-202 tablets
干预措施: BIA 3-202 (Drug)
Group 3: BIA 3-202 200 mg/placebo
Group 3: BIA 3-202 200 mg/placebo on Day 1; BIA 3-202 200 mg/placebo b.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 200 mg/placebo on Day 9.
200 mg BIA 3-202: 2 x 100 mg BIA 3-202 tablets
干预措施: Placebo (Drug)
Group 4: BIA 3-202 200 mg/placebo
Group 4: BIA 3-202 200 mg/placebo on Day 1; BIA 3-202 200 mg/placebo t.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 200 mg/placebo on Day 9.
200 mg BIA 3-202: 2 x 100 mg BIA 3-202 tablets
干预措施: BIA 3-202 (Drug)
Group 4: BIA 3-202 200 mg/placebo
Group 4: BIA 3-202 200 mg/placebo on Day 1; BIA 3-202 200 mg/placebo t.i.d. on Days 3-8 inclusively; final single dose of BIA 3-202 200 mg/placebo on Day 9.
200 mg BIA 3-202: 2 x 100 mg BIA 3-202 tablets
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) - D1
时间窗: Day 1
Time of maximum observed concentration (tmax) - D1
时间窗: Day 1
Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D1
时间窗: Day 1
Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - D1
时间窗: Day 1
Maximum observed plasma concentration (Cmax) - D9
时间窗: Day 9
Time of maximum observed concentration (tmax) - D9
时间窗: Day 9
Area under the plasma concentration time curve to last measurable time point (AUC0-t) - D9
时间窗: Day 9
Area under the plasma concentration time curve extrapolated to infinity (AUC0-∞) - D9
时间窗: Day 9
次要结局
未报告次要终点