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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245 (8245-004)(COMPLETED)

2016年2月11日 更新者:Merck Sharp & Dohme LLC

A Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8245.

A 2-period crossover study to assess the safety, tolerability and glucose-lowering effects of MK8245.

研究概览

详细说明

Hypothesis: Multiple doses of MK-8245 are sufficiently safe and well tolerated in patients with Type 2 diabetes based on an assessment of clinical and laboratory adverse experiences (AEs), to permit continued clinical investigation.

研究类型

介入性

注册 (实际的)

14

阶段

  • 阶段1

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 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

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

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: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

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

2008年10月1日

初级完成 (实际的)

2009年9月1日

研究完成 (实际的)

2009年9月1日

研究注册日期

首次提交

2008年11月7日

首先提交符合 QC 标准的

2008年11月11日

首次发布 (估计)

2008年11月13日

研究记录更新

最后更新发布 (估计)

2016年2月17日

上次提交的符合 QC 标准的更新

2016年2月11日

最后验证

2016年2月1日

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

MK8245的临床试验

3
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