A Study of GSK1325760A in Healthy Japanese Subjects
2017年1月18日 更新者:GlaxoSmithKline
Phase I Study of Ambrisentan - Single Dose Study in Healthy Japanese Male Subjects
To investigate the safety, tolerability, pharmacokinetics and the effect of food on pharmacokinetics after single oral administrations of GSK1325760A
研究概览
详细说明
Phase1 study of GSK1325760A
- A double blind, single center, randomised, placebo-controlled, partially crossover, single dose study to investigate the safety, tolerability, pharmacokinetics and to assess the effect of food on pharmacokinetics of ascending oral doses of GSK1325760A in healthy Japanese male subject -
研究类型
介入性
注册 (实际的)
32
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
20年 至 64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:
- They are considered as healthy by the investigator at screening. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, clinical laboratory tests, vital sign, 12-lead ECG, immunology tests and urinary drug screening tests.
- They are Japanese males.
- Aged 20 to 64 years, inclusive.
- They have a body mass index (weight/height2) at screening in the range of 18.5 and <25.0 kg/m2 inclusive. Standard weight is in the range of 55-85 kg inclusive.
- Blood pressure and pulse rate at screening within the normal range (systolic 90-140 mmHg, diastolic 40-90 mmHg, pulse rate 40-90bpm).
- They have the following clinical laboratory test
- Biochemistry (AST(GOT), ALT(GPT), ALP, LDH and gamma-GTP : within normal range at screening.
- Haematology (RBC, Hb and Ht) below upper limit normal range at screening.
- Normal ECG at screening (QTc value of <440msec).
- They give their consent to be able to abstain from sexual intercourse or use condom for contraception from at screening until post-study screen.
- They are capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- They are non-smokers (at least 6 months).
- They are able to attend all visits and complete the study.
Exclusion Criteria:
- The subject has any clinically relevant abnormality on medical examination, vital sign, clinical laboratory test or medical history at screening in the medical opinion of the investigator or the subject has a medical history that is not considered as eligible for inclusion in this study by the investigator.
- The subject has an allergy for any drug or idiosyncrasy. This excludes a pollen allergy without current symptoms.
- The subject has participated in a clinical study or post-marketing study with an investigational or a non-investigational product or device during the previous 4 months of the first dosing.
- The subject is concurrently participating in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational product or device.
- The subject is positive for syphilis, HBs antigen, HCV antibody, HIV antibody, HTLV-1 antibody.
- The subject is positive for urine drugs of abuse test.
- The subject has donated a unit of blood (>400mL) within the previous 4 months or (>200mL) within the previous 1 month of screening.
- The subject is currently taking regular (or a course of) medication (including prescribed drug, over-the-counter medication and herbal preparations). Medication nor permitted during the study must be discontinued 14 days prior to dosing.
- The subject has a history or current conditions of drug abuse or alcoholism according to ICD10.
- The subject has a history of regular alcohol consumption exceeding 7 drinks/week (1 drink = 350mL of beer) within 6 months of the first dosing.
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
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Adverse events Change in Clinical laboratory test Vital sign 12-lead ECG Plasma concentration Urine concentration
大体时间:on 5 or 6 days after dosing
|
on 5 or 6 days after dosing
|
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。
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1月1日
初级完成 (实际的)
2007年2月1日
研究完成 (实际的)
2007年2月1日
研究注册日期
首次提交
2007年1月16日
首先提交符合 QC 标准的
2007年1月17日
首次发布 (估计)
2007年1月18日
研究记录更新
最后更新发布 (估计)
2017年1月19日
上次提交的符合 QC 标准的更新
2017年1月18日
最后验证
2017年1月1日
更多信息
与本研究相关的术语
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.