Phase I Study to Assess the Effect on Healthy Male Volunteers of Ketoconazole on the Pharmacokinetics of a Single Dose of AZD5069 Administered Orally.
2015年6月24日 更新者:AstraZeneca
An Open-label, Fixed-sequence, Single-centre Phase I Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of AZD5069 After Oral Administration of a Single Dose AZD5069 to Healthy Male Volunteers
The main purpose of the study is to compare the change of the AZD5069 Pharmacokinetic profile when administered with ketoconazole.
Subjects will be treated first with AZD5069 only followed by a washout period before starting with the combined treatment (both ketoconazole and AZD5069).
研究概览
详细说明
An open-label, fixed-sequence, single-centre phase I study to assess the effect of ketoconazole on the pharmacokinetics of AZD5069 after oral administration of a single dose AZD5069 to healthy male volunteers
研究类型
介入性
注册 (实际的)
15
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
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London、英国
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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 50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:
- Healthy male volunteers aged 18 to 50 years (inclusive).
- Veins suitable for cannulation or repeated venipuncture.
- Healthy volunteers with neutrophil counts within the laboratory normal reference range at Screening
- Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2 calculated from height and weight at screening; minimum weight 50 kg and maximum weight 100 kg.
- Non-smokers or ex-smokers with no smoking history for the last 3 months prior to screening and a smoking history of less than 10 pack years (1 pack year = tobacco consumption corresponding to 20 cigarettes smoked per day for 1 year) at screening.
Exclusion Criteria:
- Healthy volunteers with latent tuberculosis as suggested by their history and judged by the Investigator
- Healthy volunteers who belong to a high-risk group for HIV infection.
- Known or suspected history of significant drug abuse as judged by the Investigator.
- History of alcohol abuse or excessive intake of alcohol as judged by the Investigator.
- Plasma donation within 1 month of screening or any blood donation/blood loss >500 mL during the 3 months and/or 1350 mL within the 12 months prior to screening.
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:基础科学
- 分配:非随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:First AZD5069, then Ketoconazole + AZD5069
AZD5069 in first period (on 1 day) and in second period (after wash out) ketoconazole alone (on 2 days) then ketoconazole + AZD5069 (on 1 day), then again ketoconazole alone (on 2 days)
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AZD5069 15 mg (3x5 mg capsules) single administration
Ketoconazole 400 mg (2x200 mg tablets)
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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 |
|---|---|---|
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Pharmacokinetics of AZD5069 (15 mg) and a metabolite (AZ13587715) measured by AUC, AUC(0-t), Cmax, λz, t½λz, tmax, CL/F (AZD5069 only), Vz/F (alone and in combination with Ketoconazole)
大体时间:Day 1, Day 2 at 24 hours post dose and Day 3 at 48 hours post dose in period 1 and Day 1, 2, 3 at 48 hours post dose and Day 4 at 72 post dose in period 2.
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(AUC(0-t)) area under the plasma concentration-time curve from time zero to time of last quantifiable concentration, (Cmax) observed maximum plasma concentration, (λz) terminal rate constant, (t½λz) terminal half-life, (tmax) time to reach maximum plasma concentration (tmax), (CL/F) apparent oral clearance (AZD5069 only), (Vz/F) apparent volume of distribution.
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Day 1, Day 2 at 24 hours post dose and Day 3 at 48 hours post dose in period 1 and Day 1, 2, 3 at 48 hours post dose and Day 4 at 72 post dose in period 2.
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Pharmacokinetics of Ketoconazole measured by AUC(0-t) and Cmax (in combination with AZD5069)
大体时间:Day 1, 2, 3 at 48 hours post dose and Day 4 at 72 post dose in period 2.
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Day 1, 2, 3 at 48 hours post dose and Day 4 at 72 post dose in period 2.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Numbers of circulating neutrophil in blood measured by AZD5069 administration alone and in combination with Ketoconazole
大体时间:Day 1, 2, 3 at predose, 4, 8, 12, 24, 48 hours post dose in period 1 and Day 1, 2, 3, 4 at predose, 4, 8, 12, 24, 48 hours post dose
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Day 1, 2, 3 at predose, 4, 8, 12, 24, 48 hours post dose in period 1 and Day 1, 2, 3, 4 at predose, 4, 8, 12, 24, 48 hours post dose
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Safety of AZD5069 (15 mg) in combination with Ketoconazole by assessing a panel of adverse events measures: laboratory assessments, vital signs, physical examination and 12-led electrocardiogram.
大体时间:Up to 2 months
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Measures: laboratory assessments (clinical chemistry, haematology, urinalysis), vital signs (blood pressure, pulse rate, including body temperature), physical examination and 12-led electrocardiogram.
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Up to 2 months
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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
调查人员
- 研究主任:Bengt Larsson, Dr.、AstraZeneca Pharmaceutical
- 学习椅:Gillian Pilbrow、AstraZeneca Pharmaceutical
- 首席研究员:Leonard Siew, DR.、Quintiles Drug Research Unit at Guy's Hospital
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。
有用的网址
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
2012年12月1日
初级完成 (实际的)
2013年2月1日
研究完成 (实际的)
2013年2月1日
研究注册日期
首次提交
2012年11月20日
首先提交符合 QC 标准的
2012年11月26日
首次发布 (估计)
2012年11月28日
研究记录更新
最后更新发布 (估计)
2015年6月25日
上次提交的符合 QC 标准的更新
2015年6月24日
最后验证
2015年6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
- D3550C00011
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