A Study to Assess the Safety, Tolerability and Pharmacokinetics of Lucerastat (CDP923) After Multiple Dosing in Healthy Subjects
2016年10月25日 更新者：Actelion
A Randomised Double-blind, Placebo-controlled, Ascending Multiple Dose Phase 1 Study of CDP923 in Healthy Volunteers to Assess Safety, Tolerability, Pharmacokinetics and Food Effect
The objectives of this study were to evaluate the safety and tolerability of lucerastat and to determine its pharmacokinetic profile after multiple dosing.
Also, the potential effect of food on the pharmacokinetics of lucerastat was explored following a single dose of 500 mg.
研究概览
详细说明
The subjects were to be enrolled sequentially to three dose groups, starting with the lowest dose level.
Subjects could participate in only one Group.
Progression to an increased dose of lucerastat was permitted only after review of all data from the previous cohort suggested that it was safe to do so.
研究类型
介入性
注册 (实际的)
37
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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Edinburgh、英国、EH14 4AP
- Investigator site
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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 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:
- Signed informed consent form.
- Male subjects aged from 18 to 45 years at screening.
- Body weight between 50 and 100 kg and body mass index (BMI) between 18.0 and 29.0 kg/m2 at screening.
- Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.
Exclusion Criteria:
- History or clinical evidence of any disease or medical / surgical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study treatments.
- Serious adverse reaction or hypersensitivity to any drug.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the 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
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Cohort 1 (200 mg)
Six subjects received 200 mg of lucerastat twice daily for 7 consecutive days in fasting conditions
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Capsule for oral administration containing lucerastat
其他名称：
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实验性的：Cohort 2 (500 mg)
Six subjects received 500 mg of lucerastat as a single dose in the morning of Day 1 in fed conditions.
After a 5-day washout, they received the same dose twice daily for 7 consecutive days in fasting conditions
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Capsule for oral administration containing lucerastat
其他名称：
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实验性的：Cohort 3 (500 mg)
Six subjects received 500 mg of lucerastat twice daily for 7 consecutive days in fasting conditions
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Capsule for oral administration containing lucerastat
其他名称：
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实验性的：Cohort 4 (1000 mg)
Six subjects received 1 g of lucerastat for 7 consecutive days in fasting conditions
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Capsule for oral administration containing lucerastat
其他名称：
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安慰剂比较：Placebo cohorts 1 to 4
Twelve subjects received matched placebo (3 subjects per cohort, except for Cohort 3 where 4 subjects received placebo)
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Placebo capsules matching lucerastat capsules
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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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Dose proportionality in lucerastat pharmacokinetics assessed by maximum plasma concentration (Cmax)
大体时间：PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose
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Cmax was used to assess dose proportionality across all dose groups
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PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose
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Dose proportionality in lucerastat pharmacokinetics assessed by area under the concentration-time curve (AUC)
大体时间：PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose on Day 7
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AUC from time zero to infinity [AUC(0-inf)] was used to assess dose proportionality across all dose groups
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PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose on Day 7
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Terminal elimination half-life (t1/2)
大体时间：PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose on Day 7
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t1/2 was calculated from the plasma concentrations-time curves of lucerastat after multiple doses
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PK blood samples were collected on Day 7, at pre-dose and at scheduled time points up to 48 hours after the morning dose on Day 7
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Food effect on lucerastat pharmacokinetics assessed by Cmax
大体时间：PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose
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Potential food effect on pharmacokinetic parameters of lucerastat was tested by comparing Cmax in fed vs fasted state in the 500 mg cohort (cohort 2)
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PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose
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Food effect on lucerastat pharmacokinetics assessed by AUC
大体时间：PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose
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Potential food effect on pharmacokinetic parameters of lucerastat was tested by comparing AUC in fed versus fasted state in the 500 mg cohort (cohort 2)
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PK blood samples were collected on Day 1, at pre-dose and at scheduled time points up to 12 hours after the morning dose
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Number of participants with adverse events (AEs)
大体时间：From baseline up to Day 14 (end of study)
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An AE was defined as any untoward medical occurrence in a clinical investigation subject, which did not necessarily have a causal relationship with the treatment
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From baseline up to Day 14 (end of study)
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Change from baseline in haematology after multiple doses of lucerastat
大体时间：Up to Day 9
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Up to Day 9
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Change from baseline in clinical chemistry after mutliple doses of lucerastat
大体时间：Up to Day 9
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Up to Day 9
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Change from baseline in heart rate after mutliple doses of lucerastat
大体时间：Up to Day 9
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Up to Day 9
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Change from baseline in haematology after a single dose of lucerastat
大体时间：At 24 hours post dose
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At 24 hours post dose
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Change from baseline in clinical chemistry after a single dose of lucerastat
大体时间：At 24 hours post dose
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At 24 hours post dose
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Change from baseline in heart rate after a single dose of lucerastat
大体时间：At 24 hours post dose
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At 24 hours post dose
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Change from baseline in blood pressure after a single dose of lucerastat
大体时间：Up to 24 hours post dose
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Up to 24 hours post dose
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Change from baseline in electrocardiogram (ECG) variables after a single dose of lucerastat
大体时间：Up to 24 hours post dose
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Up to 24 hours post dose
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Stool frequency after multiple doses of lucerastat
大体时间：Every day up to Day 9
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Every day up to Day 9
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Change from baseline in body weight after multiple doses of lucerastat
大体时间：At Day 9
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At Day 9
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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
- Nicolas Guérard、Actelion
出版物和有用的链接
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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
2003年12月1日
初级完成 (实际的)
2004年5月1日
研究完成 (实际的)
2004年5月1日
研究注册日期
首次提交
2016年10月24日
首先提交符合 QC 标准的
2016年10月25日
首次发布 (估计)
2016年10月26日
研究记录更新
最后更新发布 (估计)
2016年10月26日
上次提交的符合 QC 标准的更新
2016年10月25日
最后验证
2016年10月1日
更多信息
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