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临床试验/NCT01033318
NCT01033318已完成1 期

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

Merck Sharp & Dohme LLC0 个研究点目标入组 30 人开始时间: 2007年9月11日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
30
主要终点
Part I: Area under the plasma concentration (AUC) versus time curve in healthy adult male subjects in the fasted state
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 55 Years（Adult）
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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
  • •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

研究组 & 干预措施

Part 2 C-2

Experimental

Part 2; Panel C; Sequence 2:

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

干预措施: MK1809 (Drug)

Part 1 A-1

Experimental

Part 1; Panel A; Sequence 1:

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

干预措施: MK1809 (Drug)

Part 1 A-2

Experimental

Part 1; Panel A; Sequence 2:

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

干预措施: MK1809 (Drug)

Part 1 A-3

Experimental

Part 1; Panel A; Sequence 3 2 mg MK1809 / 10 mg MK1809 / Losartan / Placebo / 280 mg MK1809

干预措施: MK1809 (Drug)

Part 1 A-4

Experimental

Part 1; Panel A; Sequence 4 2 mg MK1809 / Losartan / 50 mg MK1809 / 150 mg MK1809 / Placebo

干预措施: MK1809 (Drug)

Part 1 A-5

Experimental

Part 1; Panel A; Sequence 5:

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

干预措施: MK1809 (Drug)

Part 1 B-1

Experimental

Part 1; Panel B; Sequence 1:

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

干预措施: MK1809 (Drug)

Part 1 B-2

Experimental

Part 1; Panel B; Sequence 2:

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

干预措施: MK1809 (Drug)

Part 1 B-3

Experimental

Part 1; Panel B; Sequence 3:

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

干预措施: MK1809 (Drug)

Part 1 B-4

Experimental

Part 1; Panel B; Sequence 4:

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

干预措施: MK1809 (Drug)

Part 1 B-5

Experimental

Part 1; Panel B; Sequence 5:

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

干预措施: MK1809 (Drug)

Part 2 C-1

Experimental

Part 2; Panel C; Sequence 1:

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

干预措施: MK1809 (Drug)

Part 2 C-3

Experimental

Part 2; Panel C; Sequence 3:

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

干预措施: MK1809 (Drug)

Part 2 C-4

Experimental

Part 2; Panel C; Sequence 4:

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

干预措施: MK1809 (Drug)

Part 2 C-5

Experimental

Part 2; Panel C; Sequence 5:

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

干预措施: MK1809 (Drug)

结局指标

主要结局

Part I: Area under the plasma concentration (AUC) versus time curve in healthy adult male subjects in the fasted state

时间窗: Through 32 hours postdose

Part 1: Trough plasma concentration in healthy adult male subjects in the fasted state

时间窗: 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

时间窗: Duration of study and up to 14 days after administration of the last dose of study drug

次要结局

  • 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)(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)(Through 32 hours postdose)
  • Part 1: Number of clinical and laboratory adverse experiences (AEs) to assess safety and tolerability(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(Through 32 hours postdose)
  • Part 2: Trough plasma concentration of the E3174 metabolite(Through 32 hours postdose)

研究者

申办方类型
Industry
责任方
Sponsor

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