Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long Acting GLP-1 Analogue (NNC0113-0987) in Healthy Male Subjects
2014年6月19日 更新者：Novo Nordisk A/S
This trial is conducted in Europe.
The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long acting GLP-1 analogue (NNC0113-0987) in healthy male subjects.
研究概览
研究类型
介入性
注册 (实际的)
82
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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Harrow、英国、HA1 3UJ
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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 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:
- Male, who is considered to be generally healthy, based on the medical history, physical examination and the results of vital signs, electrocardiogram (ECG) and laboratory safety tests performed during the screening visit, as judged by the investigator
- Age 18-64 years (both inclusive) at the time of signing informed consent
- BMI (body mass index) 20.0-29.9 kg/m^2 (both inclusive)
Exclusion Criteria:
- History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (GI), endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- History of chronic pancreatitis or idiopathic acute pancreatitis
- Use of prescription or non-prescription medicinal and herbal products (except routine vitamins) within three weeks preceding the dosing period. Occasional use of paracetamol or acetylsalicylic acid is permitted
- Subject with previous GI surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy
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
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：DC (dosing condition)
Escalation design.
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Once-daily doses for oral administration.
Multiple doses with sequential dose increments over 10 weeks.
Progression to next dose increment is based on a safety evaluation
Once-daily doses for oral administration
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实验性的：Oral A
Escalation design.
Planned end-dose is 5 mg.
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Once-daily doses for oral administration.
Multiple doses with sequential dose increments over 10 weeks.
Progression to next dose increment is based on a safety evaluation
Once-daily doses for oral administration
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实验性的：Oral B
Escalation design.
Planned end-dose is 10 mg.
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Once-daily doses for oral administration.
Multiple doses with sequential dose increments over 10 weeks.
Progression to next dose increment is based on a safety evaluation
Once-daily doses for oral administration
|
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实验性的：Oral C
Escalation design.
Planned end-dose is 20 mg.
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Once-daily doses for oral administration.
Multiple doses with sequential dose increments over 10 weeks.
Progression to next dose increment is based on a safety evaluation
Once-daily doses for oral administration
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Number of treatment emergent adverse events (TEAEs) recorded
大体时间：From the time of first dosing (Day 0) and until completion of the post-treatment follow-up visit (Day 83-97)
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From the time of first dosing (Day 0) and until completion of the post-treatment follow-up visit (Day 83-97)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Area under the NNC0113-0987 plasma concentration curve
大体时间：During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
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During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
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Maximum observed NNC0113-0987 plasma concentration
大体时间：During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
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During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
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Time to maximum observed NNC0113-0987 plasma concentration
大体时间：During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
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During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69)
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Change in fasting plasma glucose (FPG)
大体时间：From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)
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From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)
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Change in HbA1C (glycosylated haemoglobin)
大体时间：From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)
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From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)
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Change in body weight
大体时间：From baseline (Day -1) to after 10 weeks of treatment (Day 70)
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From baseline (Day -1) to after 10 weeks of treatment (Day 70)
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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。
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
2013年10月1日
初级完成 (实际的)
2014年5月1日
研究完成 (实际的)
2014年5月1日
研究注册日期
首次提交
2013年10月18日
首先提交符合 QC 标准的
2013年10月18日
首次发布 (估计)
2013年10月23日
研究记录更新
最后更新发布 (估计)
2014年6月20日
上次提交的符合 QC 标准的更新
2014年6月19日
最后验证
2014年6月1日
更多信息
与本研究相关的术语
其他研究编号
- NN9926-3950
- 2012-002893-30 (EudraCT编号)
- U1111-1131-8724 (其他标识符：WHO)
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.