Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Otherwise Healthy Obese Volunteers
2018年12月11日 更新者：Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Double-Blind, Randomized, Placebo-Controlled, Sequential Cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Oral Doses of JNJ-28431754 in Otherwise Healthy Obese Male and Female Subjects
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of increasing doses of canagliflozin (JNJ-28431754) in healthy obese volunteers.
研究概览
详细说明
This study will be a single-center, randomized (the treatment is assigned by chance), double-blind (neither investigator nor volunteer knows the identity of the assigned treatment), placebo-controlled (one of the study medications is inactive), ascending multiple dose study (increasing doses of study medication) to assess the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) in otherwise healthy obese volunteers.
The study will consist of 3 phases: a screening phase, a double-blind treatment phase, and an end of study (or follow-up) phase.
Volunteers will be assigned to 5 cohorts (groups) made up of 16 otherwise healthy obese men and women.
Within each group, 12 volunteers will be given canagliflozin once or twice daily and 4 volunteers will be given placebo (inactive medication) once or twice daily for 14 days.
The dose of canagliflozin will be different for each of the 5 groups and the second group will not begin treatment until at least 21 days after the first group start treatment.
This 21-day gap will be applied to all subsequent groups.
Each volunteer will participate in the study for approximately 58 days.
研究类型
介入性
注册 (实际的)
80
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
-
-
Florida
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Miramar、Florida、美国
-
-
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 60年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Volunteers must have a body mass index (BMI = weight in kg/height in m2) of 30.0 to 39.9 kg/m2
- Volunteers must be non-diabetic as confirmed by fasting plasma glucose <126 mg/dL
- Volunteers must be non-smoker or non-tobacco users (not smoked cigarettes or used tobacco-containing products for 3 months prior to screening)
Exclusion Criteria:
- History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
- History of having taken anti-obesity medications (prescription or non-prescription) within 3 months of the screening visit, or anticipates a need to take any of these drugs during the course of the study
- History of gastric banding, gastric bypass or other gastric-reduction surgery
- History of eating disorder or recent significant changes in body weight due to dieting or nutritional treatment
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：单组作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Cohort 1
Each volunteer will receive a total daily dose of 30 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
其他名称：
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
|
|
实验性的：Cohort 2
Each volunteer will receive a total daily dose of 100 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
其他名称：
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
|
|
实验性的：Cohort 3
Each volunteer will receive a total daily dose of 300 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
其他名称：
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
|
|
实验性的：Cohort 4
Each volunteer will receive a total daily dose of 600 mg of canagliflozin (JNJ-28431754) or placebo (inactive medication) on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
其他名称：
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
|
|
实验性的：Cohort 5
Each volunteer will receive 300 mg of canagliflozin (JNJ-28431754) twice daily (600 mg total daily dose) or placebo (inactive medication) twice daily on Days 1 through 14.
|
A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
其他名称：
Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
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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 |
|---|---|---|
|
Change from baseline in urine glucose excretion per day
大体时间：Day -1 (Baseline) up to Day 17
|
The change from baseline in urine excretion per day will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -1 (Baseline) up to Day 17
|
|
Change from baseline in urine glucose excretion per hour
大体时间：Day -1 (Baseline) up to Day 17
|
The change from baseline in urine excretion per hour will be compared following escalating doses of canagliflozin (JNJ-28431754).
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Day -1 (Baseline) up to Day 17
|
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Visual analog scale (VAS) scores related to hunger, satiety, fullness and prospective food consumption
大体时间：Day -2 up to Day 17
|
Visual analog scale (VAS) scores will be obtained from the VAS questionnaire.
In the VAS questionnaire, volunteers mark a point on a line (drawn between 2 statements) to indicate how they feel about the statements.
The statements about hunger are as follows: "I am not hungry at all" and "I have never been hungrier".
Other statements relate to satiety (feeling satisfied), feeling full and prospective food consumption.
Scores will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -2 up to Day 17
|
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Change from baseline in mean 24-hour plasma glucose concentrations
大体时间：Day -1 (Baseline) up to Day 16
|
The change from baseline in mean 24-hour plasma glucose concentrations will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 16
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Renal threshold for glucose excretion
大体时间：Up to Day 17
|
The point at which glucose starts to appear in the urine is known as the renal threshold.
The way in which the renal threshold varies in relation to the dose of canagliflozin (JNJ-28431754) will be calculated.
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Up to Day 17
|
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Change from baseline in mean 24-hour plasma insulin concentrations
大体时间：Day -1 (Baseline) up to Day 14
|
The change from baseline in mean 24-hour plasma insulin concentrations will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 14
|
|
Change from baseline in mean 24-hour plasma C-peptide concentrations
大体时间：Day -1 (Baseline) up to Day 14
|
The change from baseline in mean 24-hour plasma C-peptide concentrations will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 14
|
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Change from baseline in glucose excursions (after breakfast)
大体时间：Day -1 (Baseline) up to Day 14
|
Defined as the difference between the maximum glucose values observed during the 4-hour post-meal period minus the mean of the premeal measurements.
Results will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 14
|
|
Change from baseline in insulin excursions (after breakfast)
大体时间：Day -1 (Baseline) up to Day 14
|
Defined as the difference between the maximum insulin values observed during the 4-hour post-meal period minus the mean of the premeal measurements.
Results will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 14
|
|
Change from baseline in beta cell function
大体时间：Day -1 (Baseline) up to Day 14
|
Beta cell function will be calculated from the glucose, insulin, and C-peptide measurements taken post-breakfast on Day -1 up to Day 14. Results will be compared following escalating doses of canagliflozin (JNJ-28431754).
|
Day -1 (Baseline) up to Day 14
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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 (实际的)
2007年6月14日
初级完成 (实际的)
2007年12月5日
研究完成 (实际的)
2007年12月5日
研究注册日期
首次提交
2012年12月20日
首先提交符合 QC 标准的
2012年12月20日
首次发布 (估计)
2012年12月25日
研究记录更新
最后更新发布 (实际的)
2018年12月13日
上次提交的符合 QC 标准的更新
2018年12月11日
最后验证
2018年12月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- CR013765
- 28431754NAP1008 (其他标识符：Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)
药物和器械信息、研究文件
研究美国 FDA 监管的设备产品
不
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