Oral Bioavailability of Solid Formulation of GLPG1837 With and Without Food
2015年10月21日 更新者：Galapagos NV
An Open-label Study to Compare the Oral Bioavailability of an Oral Tablet of GLPG1837 Relative to an Oral Suspension After Single-dose Intake in Healthy Subjects and to Evaluate the Effect of Food on the Oral Tablet
The purpose of the study is to evaluate the amount of GLPG1837 and metabolite present in the blood (relative bioavailability) after a single oral administration of 500 mg GLPG1837 given as an oral suspension under fasted conditions as well as a tablet formulation under fasted and fed conditions, in male healthy subjects.
Also, the safety and tolerability of a single oral dose of 500 mg GLPG1837 given as an oral suspension under fasted conditions as well as a tablet formulation under fasted and fed conditions, will be assessed.
Twelve subjects will receive GLPG1837 on 3 occasions as single dose administrations: as an oral suspension fasted, as an oral tablet, fed and fasted. Treatment administrations will be separated by a wash-out period of at least 6 days.
研究概览
研究类型
介入性
注册 (实际的)
12
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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Antwerp、比利时
- SGS LSS Clinical Pharmacology Unit Antwerp
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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, age 18-50 years
- BMI between 18-30 kg/m2
Exclusion Criteria:
- Any condition that might interfere with the procedures or tests in this study
- Drug or alcohol abuse
- Smoking
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：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：GLPG1837 as oral suspension fasted
Single dose of 500 mg GLPG1837 as oral suspension after an overnight fast
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A single dose of 500 mg GLPG1837 administered as oral suspension
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实验性的：GLPG1837 as oral tablet fasted
Single dose of 500 mg GLPG1837 as oral tablet after an overnight fast
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A single dose of 500 mg GLPG1837 administered as oral tablet
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实验性的：GLPG1837 as oral tablet fed
Single dose of 500 mg GLPG1837 as oral tablet after a high-fat high-calorie breakfast
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A single dose of 500 mg GLPG1837 administered as oral tablet
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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 |
|---|---|---|
|
The maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma
大体时间：Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
|
To characterize and compare the maximum observed concentration (Cmax) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
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Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
|
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The concentration observed at 24 hours post dose (C24h) of GLPG1837 (metabolite) in plasma
大体时间：Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 2 (24h post dose) in period 3 (last dose of GLPG1837)
|
To characterize and compare the concentration observed at 24 hours post dose (C24h) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
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Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 2 (24h post dose) in period 3 (last dose of GLPG1837)
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The time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma
大体时间：Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
|
To characterize and compare the time of occurrence of Cmax (tmax) of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
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Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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The area under the plasma concentration versus time curve (AUC) of GLPG1837 (metabolite) in plasma
大体时间：Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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To characterize and compare the area under the plasma concentration versus time curve of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
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Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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The apparent terminal half-life (t1/2) of GLPG1837 (metabolite) in plasma
大体时间：Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
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To characterize and compare the apparent terminal half-life of GLPG1837 (metabolite) in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
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Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
|
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The metabolite over GLPG1837 ratios in plasma
大体时间：Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
|
To characterize and compare the metabolite over GLPG1837 ratios in plasma in male healthy subjects after a single administration of an oral suspension versus an oral tablet formulation in fasted condition, and an oral tablet formulation in fasted versus fed condition
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Between Day 1 (predose) in period 1 (first dose of GLPG1837) and Day 4 (72h post dose) in period 3 (last dose of GLPG1837)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of adverse events
大体时间：Between Screening and 7 to 10 days after the last dose of GLPG1837
|
To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of number of adverse events (AEs) reported
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Between Screening and 7 to 10 days after the last dose of GLPG1837
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Changes in vital signs as measured by heart rate, blood pressure and oral body temperature
大体时间：Between Screening and 7 to 10 days after the last dose of GLPG1837
|
To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in vital signs as measured by heart rate, blood pressure and oral body temperature reported
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Between Screening and 7 to 10 days after the last dose of GLPG1837
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Changes in 12-lead ECG measures
大体时间：Between Screening and 7 to 10 days after the last dose of GLPG1837
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To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in 12-ECG measures reported
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Between Screening and 7 to 10 days after the last dose of GLPG1837
|
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Changes in physical exam measures
大体时间：Between Screening and 7 to 10 days after the last dose of GLPG1837
|
To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in physical examination reported
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Between Screening and 7 to 10 days after the last dose of GLPG1837
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Changes in blood safety lab parameters
大体时间：Between Screening and 7 to 10 days after the last dose of GLPG1837
|
To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in blood safety lab parameters reported
|
Between Screening and 7 to 10 days after the last dose of GLPG1837
|
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Changes in urine safety lab parameters
大体时间：Between Screening and 7 to 10 days after the last dose of GLPG1837
|
To evaluate the safety and tolerability of a single dose of GLPG1837 administered as oral suspension fasted, oral tablet fasted versus fed in male healthy subjects in terms of changes in urine safety lab parameters reported
|
Between Screening and 7 to 10 days after the last dose of GLPG1837
|
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
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
2015年9月1日
初级完成 (实际的)
2015年10月1日
研究完成 (实际的)
2015年10月1日
研究注册日期
首次提交
2015年9月23日
首先提交符合 QC 标准的
2015年9月27日
首次发布 (估计)
2015年9月29日
研究记录更新
最后更新发布 (估计)
2015年10月23日
上次提交的符合 QC 标准的更新
2015年10月21日
最后验证
2015年10月1日
更多信息
与本研究相关的术语
其他研究编号
- GLPG1837-CL-103
- 2015-002518-55 (EudraCT编号)
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.