A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245 (8245-004)(COMPLETED)
A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 阶段1
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Subject has a diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or a single oral anti-hyperglycemic agent
- Subject is willing to follow the weight-maintaining diet and exercise program or equivalent beginning 4 weeks before receiving study drug, throughout the study and until the post study visit
- Subject has been a nonsmoker and/or has not used nicotine-containing products for at least approximately 6 months
Exclusion Criteria:
- Subject has a history of stroke, chronic seizures, or major neurological disorder
- Subject has a history of neoplastic disease (except non-melanomatous skin carcinoma, carcinoma in situ of the cervix, other malignancies successfully treated at least 10 years prior to screening, or malignancies deemed highly unlikely to recur.)
- Subject has a history of Type 1 Diabetes Mellitus and/or history of ketoacidosis
- Subject has a history of contact lens use within approximately the previous 6 months
- Subject has been diagnosed with dry eye syndrome
- Subject has used lipid-lowering therapies in the past 3 months (Subjects on a stable monotherapy dose of statins may be included)
- Subject has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 4 weeks of starting in the study
学习计划
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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
安慰剂比较:2个
安慰剂比较
|
MK8245 placebo capsules twice daily for 13 days.
On Day 14, only the morning dose of study medication will be taken.
There will be a 14 day washout period.
Patients will then crossover to MK8245 50 mg capsules twice daily for 13 days.
On Day 14, only the morning dose of study drug will be taken.
|
实验性的:1
MK8245
|
MK8245 50 mg capsules twice daily for 13 days.
On Day 14, only the morning dose of study medication will be taken.
There will be a 14 day washout period.
Patients will then crossover to MK8245 placebo capsules twice daily for 13 days.
On Day 14, only the morning dose of study drug will be taken.
|
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 |
---|---|---|
Number of Participants Experiencing Clinical and Laboratory Adverse Events (CAEs and LAEs)
大体时间:56 days
|
An LAE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A CAE is defined similarly but also includes changes in structure or function of the body. Serious AEs are those occuring that result in one or more of the pre-specified outcome(s) that meet the criteria of seriousness, including death, life-threatening, significant disability, or hospitalization, etc. Drug-relatedness was determined by the investigator based on clinical judgement. |
56 days
|
Mean Change From Baseline in Hepatic Glucose Production (HGP) at Day 14
大体时间:Day 14 of each 14-day Treatment Period
|
Changes in HGP were determined during a euglycemic clamp procedure.
HGP was evaluated as milligrams per kilogram of glucose produced per minute.
|
Day 14 of each 14-day Treatment Period
|
其他结果措施
结果测量 |
大体时间 |
---|---|
Hepatic Glucose Production (HGP) at Baseline
大体时间:Baseline
|
Baseline
|
合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 8245-004
- 2008_582
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.
2型糖尿病的临床试验
-
Jin-Hee AhnAsan Medical Center未知HER-2基因扩增 | HER-2 蛋白过表达
-
Tianjin Medical University Second HospitalJiangsu HengRui Medicine Co., Ltd.未知
-
AIM Vaccine Co., Ltd.Ningbo Rongan Biological Pharmaceutical Co. Ltd.; LiveRNA Therapeutics Inc.招聘中
-
AIM Vaccine Co., Ltd.Ningbo Rongan Biological Pharmaceutical Co. Ltd.; LiveRNA Therapeutics Inc.尚未招聘SARS-CoV-2
-
Ridgeback Biotherapeutics, LPMerck Sharp & Dohme LLC完全的
-
Peking UniversityCenters for Disease Control and Prevention, China; Beijing Pinggu District Hospital; Peking University...完全的