此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

A Study of the Pharmacokinetics and Pharmacodynamics of MK1809 (1809-001)(COMPLETED)

2018年9月25日 更新者:Merck Sharp & Dohme LLC

A Double-Blind, Double Dummy, Randomized, Placebo-Controlled, Alternating Panel, Single Oral Rising Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of MK1809 in Healthy Young Volunteers

The goal of this study is to identify at least one safe and well tolerated dose of MK1809 that has similar pharmacokinetic qualities as 100 mg losartan.

研究概览

研究类型

介入性

注册 (实际的)

30

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 55年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

Part 1:

  • Nonsmoker for at least 6 months
  • Body Mass Index (BMI) less than or equal to 29 kg/m2
  • In overall good health

Part 2:

  • Body Mass Index (BMI) greater than 18kg/m2 and less than or equal to 35kg/m2
  • In overall good health (patients with hypertension and/or hyperlipidemia are accepted)

Exclusion Criteria:

Part 1:

  • History of any cardiovascular disease or any clinically significant family history of cardiac arrhythmias or conduction abnormalities at an age less than 60 years
  • History of any major endocrine, vascular, hematologic, gastrointestinal, hepatic, renal or genitourinary disease/disorder
  • History of cancer
  • Clinically significant history of a neurological disorder (includes epilepsy,stroke, transient ischemic attack, classic migraines)
  • Active or history of a psychiatric disorder (includes depression, bipolar disorder, schizophrenia, anxiety)
  • History of asthma, severe wheezing, COPD, or other pulmonary disease
  • Individual or family history of bleeding or hemorrhagic diathesis, or bleeding difficulties
  • Major surgery, donated blood or participated in another investigational drug(s) trial within 30 days
  • Illicit drug use (including recreational); or history of drug or alcohol abuse (within 2 years)
  • Nitrate therapy within 4 weeks
  • History of significant drug allergy or history of food allergies

Part 2

  • History of any clinically significant cardiac or cardiovascular disease (other than hypertension)
  • History of any major endocrine, vascular, hematologic, gastrointestinal, hepatic, renal or genitourinary disease/disorder
  • History of cancer
  • History of a neurological disorder (includes epilepsy,stroke, transient ischemic attack, classic migraines)
  • Active or history of a psychiatric disorder (includes depression, bipolar disorder, schizophrenia, anxiety)
  • History of asthma, severe wheezing, COPD, or other pulmonary disease
  • Individual or family history of bleeding or hemorrhagic diathesis, or bleeding difficulties
  • Illicit drug use (including recreational); or history of drug or alcohol abuse (within 2 years)
  • Surgery, significant blood loss, donated blood, or participated in another investigational drug(s) trial within 30 days
  • Nitrate therapy within 4 weeks
  • History of significant drug allergy

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
实验性的:Part 1 A-1

Part 1; Panel A; Sequence 1:

2 mg MK1809 / placebo / 50 mg MK1809 / 150 mg MK1809 / 100 mg Losartan

single oral doses of MK1809
single oral doses of 100 mg Losartan
其他名称:
  • 氯沙坦
Placebo to MK1809
实验性的:Part 1 A-2

Part 1; Panel A; Sequence 2:

Losartan / 10 mg MK1809 / placebo / 150 mg MK1809 / 280 mg MK1809

single oral doses of MK1809
single oral doses of 100 mg Losartan
其他名称:
  • 氯沙坦
Placebo to MK1809
实验性的:Part 1 A-3
Part 1; Panel A; Sequence 3 2 mg MK1809 / 10 mg MK1809 / Losartan / Placebo / 280 mg MK1809
single oral doses of MK1809
single oral doses of 100 mg Losartan
其他名称:
  • 氯沙坦
Placebo to MK1809
实验性的:Part 1 A-4
Part 1; Panel A; Sequence 4 2 mg MK1809 / Losartan / 50 mg MK1809 / 150 mg MK1809 / Placebo
single oral doses of MK1809
single oral doses of 100 mg Losartan
其他名称:
  • 氯沙坦
Placebo to MK1809
实验性的:Part 1 A-5

Part 1; Panel A; Sequence 5:

Placebo / 10 mg MK1809 / 50 mg MK1809 / Losartan / 280 mg MK1809

single oral doses of MK1809
single oral doses of 100 mg Losartan
其他名称:
  • 氯沙坦
Placebo to MK1809
实验性的:Part 1 B-1

Part 1; Panel B; Sequence 1:

5 mg MK1809 / Placebo / 100 mg MK1809 / 210 mg MK1809 / Placebo with food

single oral doses of MK1809
Placebo to MK1809
实验性的:Part 1 B-2

Part 1; Panel B; Sequence 2:

5 mg MK1809 / 25 mg MK1809/ Placebo / Losartan / 25 mg MK1809 with food

single oral doses of MK1809
single oral doses of 100 mg Losartan
其他名称:
  • 氯沙坦
Placebo to MK1809
实验性的:Part 1 B-3

Part 1; Panel B; Sequence 3:

5 mg MK1809 / Losartan / 100 mg MK1809 / 210 mg MK1809 / Losartan with food

single oral doses of MK1809
single oral doses of 100 mg Losartan
其他名称:
  • 氯沙坦
实验性的:Part 1 B-4

Part 1; Panel B; Sequence 4:

Losartan / 25 mg MK1809/ 100 mg MK1809 / Placebo / 25 mg MK1809 with food

single oral doses of MK1809
single oral doses of 100 mg Losartan
其他名称:
  • 氯沙坦
Placebo to MK1809
实验性的:Part 1 B-5

Part 1; Panel B; Sequence 5:

Placebo / 25 mg MK1809/ Losartan / 210 mg MK1809 / 25 mg MK1809 with food

single oral doses of MK1809
single oral doses of 100 mg Losartan
其他名称:
  • 氯沙坦
Placebo to MK1809
实验性的:Part 2 C-1

Part 2; Panel C; Sequence 1:

50 mg MK1809 / Placebo / 150 mg MK1809 / 210 mg MK1809 / Losartan

single oral doses of MK1809
single oral doses of 100 mg Losartan
其他名称:
  • 氯沙坦
Placebo to MK1809
实验性的:Part 2 C-2

Part 2; Panel C; Sequence 2:

50 mg MK1809 / 100 mg MK1809/ Placebo / Losartan / 280 mg MK1809

single oral doses of MK1809
single oral doses of 100 mg Losartan
其他名称:
  • 氯沙坦
Placebo to MK1809
实验性的:Part 2 C-3

Part 2; Panel C; Sequence 3:

Losartan / 100 mg MK1809/ 150 mg MK1809 / 210 mg MK1809 / Placebo

single oral doses of MK1809
single oral doses of 100 mg Losartan
其他名称:
  • 氯沙坦
Placebo to MK1809
实验性的:Part 2 C-4

Part 2; Panel C; Sequence 4:

50 mg MK1809 / Losartan / 150 mg MK1809 / Placebo / 280 mg MK1809

single oral doses of MK1809
single oral doses of 100 mg Losartan
其他名称:
  • 氯沙坦
Placebo to MK1809
实验性的:Part 2 C-5

Part 2; Panel C; Sequence 5:

Placebo / 100 mg MK1809/ Losartan / 210 mg MK1809 / 280 mg MK1809

single oral doses of MK1809
single oral doses of 100 mg Losartan
其他名称:
  • 氯沙坦
Placebo to MK1809

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Part I: Area under the plasma concentration (AUC) versus time curve in healthy adult male subjects in the fasted state
大体时间:Through 32 hours postdose
Through 32 hours postdose
Part 1: Trough plasma concentration in healthy adult male subjects in the fasted state
大体时间:24 hours postdose
24 hours postdose
Part 2: Safety and tolerability of rising single oral doses of MK1809 in adult hypertensive patients based on an assessment of clinical and laboratory adverse experiences
大体时间:Duration of study and up to 14 days after administration of the last dose of study drug
Duration of study and up to 14 days after administration of the last dose of study drug

次要结果测量

结果测量
大体时间
Part 1: Area under the plasma concentration (AUC) versus time curve resulting from a single oral dose of MK1809 following a standard high-fat breakfast (compared to that observed with the identical dose level administered in the fasted state)
大体时间:24 hours postdose
24 hours postdose
Part 1: Maximum concentration of drug in the plasma (Cmax) resulting from a single oral dose of MK1809 following a standard high-fat breakfast (compared to that observed with the identical dose level administered in the fasted state)
大体时间:Through 32 hours postdose
Through 32 hours postdose
Part 1: Number of clinical and laboratory adverse experiences (AEs) to assess safety and tolerability
大体时间:Duration of study and up to 14 days after administration of the last dose of study drug
Duration of study and up to 14 days after administration of the last dose of study drug
Part 2: Area under the plasma concentration (AUC) versus time curve of the E3174 metabolite
大体时间:Through 32 hours postdose
Through 32 hours postdose
Part 2: Trough plasma concentration of the E3174 metabolite
大体时间:Through 32 hours postdose
Through 32 hours postdose

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。

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9月11日

初级完成 (实际的)

2008年6月19日

研究完成 (实际的)

2008年6月19日

研究注册日期

首次提交

2009年12月15日

首先提交符合 QC 标准的

2009年12月15日

首次发布 (估计)

2009年12月16日

研究记录更新

最后更新发布 (实际的)

2018年9月26日

上次提交的符合 QC 标准的更新

2018年9月25日

最后验证

2018年9月1日

更多信息

与本研究相关的术语

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.

订阅