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Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453

2016年7月20日 更新者：Bial - Portela C S.A.

A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Six Multiple Rising Dose Regimens of BIA 5-453 in Healthy Male Volunteers

The purpose of this study is to assess the tolerability of BIA 5-453 after six multiple rising dose regimens of BIA 5-453.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Two centres, double-blind, randomised, placebo-controlled study of six dosage regimens of BIA 5-453 in six groups of healthy male subjects.

In each group, the study consisted of a 10-day multiple-dose period. Progression to the next dose level only occurred if the previous dose level was considered to be safe and well tolerated. An appropriate interval separated the investigation of doses to permit a timely review and evaluation of safety data (including plasma exploratory pharmacokinetics) prior to proceeding to a higher dose level.

研究类型

介入性

注册 (实际的)

57

阶段

  • 阶段1

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 45年 (成人)

接受健康志愿者

是的

有资格学习的性别

男性

描述

Inclusion Criteria:

  1. A signed and dated informed consent form before any study-specific screening procedure was performed.
  2. Aged between 18 and 45 years, inclusive.
  3. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs and digital 12-lead ECG.
  4. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must have been able to abstain from smoking during the inpatient stay.
  5. Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

Medical History

  1. Any significant cardiovascular (e.g. hypertension), hepatic, renal, respiratory (e.g. childhood asthma), gastrointestinal, endocrine (e.g. diabetes, dyslipidemia), immunologic, dermatological, haematological, neurologic, or psychiatric disease.
  2. Acute disease state (e.g., nausea, vomiting, fever, diarrhoea) within 7 days before study Day1.
  3. History of drug abuse within 1 year before study Day1.
  4. History of alcoholism within 1 year before Day1. Consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12 g; 4 cL of aperitif, 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g

  5. History of any clinically important drug allergy.

    Physical and Laboratory Findings

  6. An automatic ECG QTc interval reading at screening or enrolment >450 ms.
  7. Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.

  8. Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA [3,4-methylenedioxy-methamphetamine; ecstasy]).

    Prohibited treatments

  9. Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product (IMP) administration.
  10. Consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 72 before study day -1.
  11. Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before IMP administration.
  12. Donation of blood (ie 450 ml) within 90 days before study Day1.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：BIA 5-453 25 mg or placebo
Multiple oral doses of BIA 5-453 25 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
药品：BIA 5-453
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
其他名称：
  • 依他司他
药品：Placebo
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
实验性的：BIA 5-453 50 mg or placebo
Multiple oral doses of BIA 5-453 50 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
药品：BIA 5-453
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
其他名称：
  • 依他司他
药品：Placebo
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
实验性的：BIA 5-453 100 mg or placebo
Multiple oral doses of BIA 5-453 100 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
药品：BIA 5-453
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
其他名称：
  • 依他司他
药品：Placebo
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
实验性的：BIA 5-453 200 mg or placebo
Multiple oral doses of BIA 5-453 200 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
药品：BIA 5-453
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
其他名称：
  • 依他司他
药品：Placebo
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
实验性的：BIA 5-453 400 mg or placebo
Multiple oral doses of BIA 5-453 400 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
药品：BIA 5-453
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
其他名称：
  • 依他司他
药品：Placebo
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
实验性的：BIA 5-453 600 mg or placebo
Multiple oral doses of BIA 5-453 600 mg or placebo were administered once daily for 10 days to subjects in fasting conditions.
药品：BIA 5-453
Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
其他名称：
  • 依他司他
药品：Placebo
The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percent of subjects with at least one adverse event
大体时间：through study completion, an average of 10 days
through study completion, an average of 10 days
Percent of subjects by dose group with at least one treatment-emergent adverse event (TEAEs)
大体时间：through study completion, an average of 10 days
Treatment-emergent adverse events are adverse events that occurred either in the 72 hours after dosing or that was present prior to dosing but exacerbated within 72 hours after dosing.
through study completion, an average of 10 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bial - Portela C S.A.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年9月1日

初级完成 (实际的)

2008年7月1日

研究完成 (实际的)

2008年7月1日

研究注册日期

首次提交

2016年7月19日

首先提交符合 QC 标准的

2016年7月20日

首次发布 (估计)

2016年7月21日

研究记录更新

最后更新发布 (估计)

2016年7月21日

上次提交的符合 QC 标准的更新

2016年7月20日

最后验证

2016年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • BIA-5453-102
  • 2007-004142-33 (EudraCT编号)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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