GSK2018682 FTIH in Healthy Volunteers (P1A114070)
2017年6月7日 更新者:GlaxoSmithKline
A Single-blind, Placebo-controlled, Two Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of GSK2018682 in Healthy Volunteers
This protocol describes the first administration of GSK2018682 to humans.
The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of GSK2018682.
The study will also provide preliminary evidence of the potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte counts.
研究概览
详细说明
This protocol describes the first administration of GSK2018682 to humans.
The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of GSK2018682.
The study will also provide preliminary evidence of the potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte counts.
研究类型
介入性
注册 (实际的)
27
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
New South Wales
-
Randwick、New South Wales、澳大利亚、2031
- GSK Investigational Site
-
-
South Australia
-
Adelaide、South Australia、澳大利亚、5000
- GSK Investigational Site
-
-
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 55年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters significantly outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with lymphocyte counts outside the normal range should always be excluded from enrollment
- BMI within the range 19 - 28 kg/m2 (inclusive).
Exclusion Criteria:
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption
- Subjects with a history of, or examination suspicious for, skin cancer(s) including melanoma, basal cell or squamous cell carcinoma.
- Systolic blood pressure less than 95 mmHg or greater than 140 mmHg, or diastolic blood pressure less than or equal to 50 mmHg or greater than or equal to 95 mmHg.
- Symptomatic reduction in blood pressure after orthostatic challenge.
- Subjects with resting heart rate less than 45 beats per minute or greater than 90 beats per minute
Other criteria may apply as defined by the clinical protocol.
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:交叉作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Part A
Part A will be used to confirm the prediction of GSK2018682 PK, assess its effects on lymphocytes, and monitor its safety profile in a single cohort (Cohort 1).
Cohort 1 will consist of 4 subjects and explore 4 doses of GSK2018682 in 4 study sessions.
In each session, three subjects will receive GSK2018682 and one subject will receive placebo.
Thus, when the cohort completes, each subject will receive placebo and 3 doses of GSK2018682.
|
GSK2018682
匹配的安慰剂
|
|
实验性的:Part B
Part B will explore doses to refine the dose-response curve of GSK2018682 on lymphocyte suppression, as allowed by stopping criteria, in 1 or 2 cohorts of up to 15 subjects (Cohort 2 and Cohort 3).
In Part B, up to six single ascending doses of GSK2018682 and one dose of placebo will be investigated in up to 8 sessions.
|
GSK2018682
匹配的安慰剂
|
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 |
|---|---|---|
|
To investigate the safety and tolerability of single escalating oral doses of GSK2018682
大体时间:Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
|
Adverse event and safety lab monitoring
|
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
|
|
To investigate effects of GSK2018682 on heart rate and blood pressure
大体时间:Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
|
12 lead ECG and telemetry monitoring plus vital signs (systolic and diastolic blood blood pressures), heart rate, respiratory rate and temperature
|
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
|
|
To investigate the pharmacokinetics of single doses of GSK2018682
大体时间:Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
|
Peak blood concentration, time of peak blood concentration, oral clearance, half life and AUC
|
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
|
|
Evaluate the effect of single escalating oral doses of GSK2018682 on lymphocytes (totals plus subsets)
大体时间:Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
|
Reduction from baseline in lymphocyte counts obtained at different time points after dosing and at different dose levels
|
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 12 weeks
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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 (实际的)
2010年5月21日
初级完成 (实际的)
2010年12月20日
研究完成 (实际的)
2010年12月20日
研究注册日期
首次提交
2011年4月14日
首先提交符合 QC 标准的
2011年6月30日
首次发布 (估计)
2011年7月4日
研究记录更新
最后更新发布 (实际的)
2017年6月9日
上次提交的符合 QC 标准的更新
2017年6月7日
最后验证
2017年6月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 114070
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
研究数据/文件
-
个人参与者数据集
信息标识符:114070信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
临床研究报告
信息标识符:114070信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
研究协议
信息标识符:114070信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
统计分析计划
信息标识符:114070信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
带注释的病例报告表
信息标识符:114070信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
知情同意书
信息标识符:114070信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
数据集规范
信息标识符:114070信息评论:For additional information about this study please refer to the GSK Clinical Study Register
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.