A Study of Single Dose MK-3614 (MK-3614-001)(COMPLETED)
2019年6月24日 更新者：Merck Sharp & Dohme LLC
A Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-3614
This study will determine if MK-3614, given as single doses, is safe and well tolerated in healthy males and male participants with mild to moderate hypertension.
研究概览
详细说明
Up to three planned panels of either 8 healthy participants (Panels A and B) or 8 participants with mild to moderate hypertension (Panel C) will be enrolled.
In Panels A and B, 8 participants will alternately receive single rising doses of MK-3614 or placebo.
All doses will be administered in the fasted state, except Panel A, Period 3 in which a standard high-fat breakfast provided approximately 30 minutes prior to dosing.
Panel A will begin first.
At least 3 days will elapse before participants in the alternate panel (Panel B) will receive the next higher dose.
In Panel C, 8 mild to moderate hypertensive male participants will receive single rising doses of MK-8892 or placebo.
For all panels, there will be at least 7 days washout between treatment periods for any given participant.
Participants may only be enrolled in one panel of the study.
All participants in periods of all panels (with exception of 0.25 mg fasted/fed periods) will be randomly assigned to either study drug or placebo, i.e., a participant could be assigned to receive study drug in one period and placebo in another.
As per the protocol allocation plan, the same participants will receive 0.25 mg MK-3612 in a fasted and fed state.
研究类型
介入性
注册 (实际的)
24
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
男性
描述
Inclusion Criteria:
- Healthy participants between 18 to 45 years of age; otherwise healthy participants between 18 to 55 years of age newly diagnosed with grade 1 or 2 hypertension
- Participant is in good general health
- Participant is a nonsmoker
Exclusion Criteria:
- Participant has a history of stroke, seizure or major neurological disease
- Participant has functional disability that can interfere with rising from a sitting position to a standing position
- Participant has a family history of a bleeding or clotting disorder
- Participant has a history of cancer
- Participant is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study
- Participant consumes excessive amounts of alcohol or caffeine
- Participant has had major surgery, donated blood or participated in another investigational study in the past 4 weeks.
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 |
|---|---|
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实验性的：Panel A - Healthy
Healthy participants receive single oral dose of MK-3614 0.25 mg, 1.25 mg, 0.25 mg w/ food, 0.75 mg or matching placebo.
There is at least a 7-day washout between the 4 dosing periods.
All doses were administered after an 8-hour fast except for Period 3. Period 3 dose was administered after the ingestion of a high-fat breakfast.
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实验性的：Panel B - Healthy
Healthy participants receive single oral dose of MK-3614 0.5 mg.
0.75 mg, 0.25 mg twice a day (b.i.d.), 0.25 mg three times a day (t.i.d), or matching placebo.
There is at least a 7-day washout between the 4 dosing periods.
All doses were administered after an 8-hour fast
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实验性的：Panel C - Hypertensive
Hypertensive participants receive single oral dose of MK-3614 0.75 mg.
0.5 mg.
0.75 mg, 0.75 mg or matching placebo.
There is at least a 7-day washout between the 4 dosing period.
All doses were administered after an 8-hour fast
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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 |
|---|---|---|
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Percentage of Participants Who Reported 1 or More Adverse Event (AE) - Healthy Participants
大体时间：up to 7 days for each dose level
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An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment.
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product.
The percentage of participants that reported at least 1 AE was summarized.
AEs are reported by the dose taken at the time of the event.
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up to 7 days for each dose level
|
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Percentage of Participants Who Were Discontinued From the Study Due to an AE - Healthy Participants
大体时间：up to 7 days for each dose level
|
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment.
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product.
The percentage of participants who were discontinued from the study due to an AE were summarized.
AEs are reported by the dose taken at the time of the event.
|
up to 7 days for each dose level
|
|
Percentage of Participants Who Report 1 or More Adverse Event (AE) - Hypertensive Participants
大体时间：up to 7 days for each dose level
|
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment.
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product.
The percentage of participants that reported at least 1 AE was summarized.
The percentage of participants that reported at least 1 AE was summarized.
AEs are reported by the dose taken at the time of the event.
|
up to 7 days for each dose level
|
|
Percentage of Participants Who Were Discontinued From the Study Due to an AE - Hypertensive Participants
大体时间：up to 7 days for each dose level
|
An AE was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment.
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product.
The percentage of participants who were discontinued from the study due to an AE were summarized.
AEs are reported by the dose taken at the time of the event.
|
up to 7 days for each dose level
|
|
Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of MK-3614 - Healthy Participants
大体时间：Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the AUC0-inf of MK-3614 in healthy participants.
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Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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Maximum Concentration (Cmax) of MK-3614- Healthy Participants
大体时间：Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the Cmax of MK-3614 in healthy participants.
|
Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
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Time to Cmax (Tmax) of MK-3614- Healthy Participants
大体时间：Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the Tmax of MK-3614 in healthy participants.
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Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
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Apparent Terminal Half-life (t1/2) of MK-3614- Healthy Participants
大体时间：Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the t1/2 of MK-3614 in healthy participants.
|
Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
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Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of MK-3614 - Hypertensive Participants
大体时间：Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the AUC0-inf of MK-3614 in hypertensive participants
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Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
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Maximum Concentration (Cmax) of MK-3614- Hypertensive Participants
大体时间：Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the Cmax of MK-3614 in hypertensive participants
|
Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
|
Time to Cmax (Tmax) of MK-3614- Hypertensive Participants
大体时间：Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the Tmax of MK-3614 in hypertensive participants
|
Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
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Apparent Terminal Half-life (t1/2) of MK-3614 of MK-3614- Hypertensive Participants
大体时间：Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the t1/2 of MK-3614 in hypertensive participants
|
Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
|
Change From Baseline in Heart Rate - Healthy Participants
大体时间：Baseline and 24 hours post-dose for each dose level
|
Heart rate measurements were obtained using a validated, semi-automated oscillometric device.
The difference between the predose (baseline) measurement and the measurement 24 obtained 24 hours postdose was summarized.
Data for each specific dose were combined regardless of panel.
|
Baseline and 24 hours post-dose for each dose level
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Change From Baseline in Brachial Arterial Systolic Blood Pressure - Healthy Participants
大体时间：Baseline and 24 hours postdose for each dose level
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Brachial arterial systolic blood pressure measurements were obtained using a validated, semi-automated oscillometric device.
The difference between the predose (baseline) measurement and the measurement 24 obtained 24 hours postdose was summarized.
Data for each specific dose were combined regardless of panel.
|
Baseline and 24 hours postdose for each dose level
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Change From Baseline in Brachial Arterial Diastolic Blood Pressure - Healthy Participants
大体时间：Baseline and 24 hours postdose for each dose level
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Brachial arterial diastolic blood pressure measurements were obtained using a validated, semi-automated oscillometric device.
The difference between the predose (baseline) measurement and the measurement 24 obtained 24 hours postdose was summarized.
Data for each specific dose were combined regardless of panel.
|
Baseline and 24 hours postdose for each dose level
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Change From Baseline in Heart Rate - Hypertensive Participants
大体时间：Baseline and 24 hours postdose for each dose level
|
HR measurements were obtained using a validated, semi-automated oscillometric device.
The difference between the predose (baseline) measurement and the measurement 24 obtained 24 hours postdose was summarized.
Data for each specific dose were combined regardless of sequence.
|
Baseline and 24 hours postdose for each dose level
|
|
Change From Baseline in Brachial Arterial Systolic Blood Pressure - Hypertensive Participants
大体时间：Baseline and 24 hours postdose for each dose level
|
Brachial arterial systolic blood pressure measurements were obtained using a validated, semi-automated oscillometric device.
The difference between the predose (baseline) measurement and the measurement 24 obtained 24 hours postdose was summarized.
Data for each specific dose were combined regardless of sequence.
|
Baseline and 24 hours postdose for each dose level
|
|
Change From Baseline in Brachial Arterial Diastolic Blood Pressure - Hypertensive Participants
大体时间：Baseline and 24 hours postdose for each dose level
|
Brachial arterial diastolic blood pressure measurements were obtained using a validated, semi-automated oscillometric device.
The difference between the predose (baseline) measurement and the measurement 24 obtained 24 hours postdose was summarized.
Data for each specific dose were combined regardless of sequnce.
|
Baseline and 24 hours postdose for each dose level
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Area Under the Concentration Time-curve From Hour 0 to Infinity (AUC0-inf) of 0.25 mg MK-3614 - Healthy Participants- Fasted Versus Fed
大体时间：Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the AUC0-inf of 0.25 mg MK-3614 in healthy participant when administered after an 8 hour fast and after a high-fat breakfest.
|
Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
|
Maximum Concentration (Cmax) of 0.25 mg MK-3614 - Healthy Participants- Fasted Versus Fed
大体时间：Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
Blood samples taken at Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose of each dosing period to determine the Cmax of 0.25 mg MK-3614 when administered after an 8 hour fast and after a high-fat breakfest.
|
Predose, and 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours postdose for each dose level
|
|
Percentage Change From Baseline in Augmentation Index (AIx) at 24 Hours Postdose - Healthy Participants
大体时间：Baseline and 24 hours postdose for each dose level
|
Augmentation index was measured at predose (baseline), and 1, 4, 8, 12, and 24 hours postdose by aplanation tonometry of radial artery.
The change from baseline at 24 hours postdose was summarized.
Data for each specific dose were combined regardless of panel.
|
Baseline and 24 hours postdose for each dose level
|
|
Percentage Change From Baseline in Augmentation Index (AIx) at 24 Hours Postdose - Hypertensive Participants
大体时间：Baseline and 24 hours postdose for each dose level
|
Augmentation index was measured at predose (baseline), and 1, 4, 8, 12, and 24 hours postdose by aplanation tonometry of radial artery.
The change from baseline at 24 hours postdose was summarized.
|
Baseline and 24 hours postdose for each dose level
|
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Percentage Change From Baseline in Bleeding Time at 24 Hours Postdose - Healthy Participants
大体时间：Baseline and 24 hours postdose for each dose level
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Blood was to be drawn at predose (baseline) and 3 and 24 hours postdose and bleeding time was to be assessed using a Newborn Surgicutt device.
Change in bleeding time from baseline at 24 hours postdose were to be summarized.
Due to change in number of blood draws and total blood volume restrictions, bleeding time assessment was not performed as planned.
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Baseline and 24 hours postdose for each dose level
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Percentage Change From Baseline in Bleeding Time at 24 Hours Postdose- Hypertension Participants
大体时间：Baseline and 24 hours postdose for each dose level
|
Blood was to be drawn at predose (baseline) and 3 and 24 hours postdose and bleeding time was to be assessed using a Newborn Surgicutt device.
Change in bleeding time from baseline at 24 hours postdose were to be summarized.
Due to change in number of blood draws and total blood volume restrictions, bleeding time assessment was not performed as planned.
|
Baseline and 24 hours postdose for each dose level
|
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Percentage Change in Cyclic Guanosine Monophosphate (GMP) From Baseline at 24 Hours Postdose - Healthy Participants
大体时间：Baseline and 24 hours postdose for each dose level
|
Blood was drawn at predose (baseline) and 1, 4, 8, and 24 hours postdose.
The change in cyclic GMP at 24 hours postdose was summarized.
Due to change in number of blood draws and total blood volume restrictions, data for GMP were only collected for first 2 periods of each panel.
Therefore only limited data were available and summarized.
Data for each specific dose were combined regardless of panel.
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Baseline and 24 hours postdose for each dose level
|
|
Percentage Change in Cyclic Guanosine Monophosphate (GMP) From Baseline at 24 Hours Postdose - Hypertension Participants
大体时间：Baseline and 24 hours postdose for each dose level
|
Blood was drawn at predose (baseline) and 1, 4, 8, and 24 hours postdose.
The change in cyclic GMP at 24 hours postdose was summarized.
Due to change in number of blood draws and total blood volume restrictions, data for GMP were only collected for first 2 periods of each panel.
Therefore only limited data were available and summarized.
|
Baseline and 24 hours postdose for each dose level
|
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Percentage Change From Baseline in Platelet Aggregation at 24 Hours Postdose - Healthy Participants
大体时间：Baseline and 24 hours postdose for each dose level
|
Platelet aggregation induced by adenosine diphosphate (ADP) was measured at predose (baseline) and 3 and 24 hours postdose.
Percent inhibition from baseline at 24 hours postdose was calculated.
Due to change in number of blood draws and total blood volume restrictions, data for platelet aggregation were only collected for first 2 periods of each panel.
Therefore only limited data were available and summarized.
Data for each specific dose were combined regardless of panel.
|
Baseline and 24 hours postdose for each dose level
|
|
Percentage Change From Baseline in Platelet Aggregation at 24 Hours Postdose - Hypertensive Participants
大体时间：Baseline and 24 hours postdose for each dose level
|
Platelet aggregation induced by adenosine diphosphate (ADP) was measured at predose (baseline) and 3 and 24 hours postdose.
Percent inhibition from baseline at 24 hours postdose was calculated.
Due to change in number of blood draws and total blood volume restrictions, data for platelet aggregation were only collected for first 2 periods of each panel.
Therefore only limited data were available and summarized.
|
Baseline and 24 hours postdose for each dose level
|
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)
2008年11月1日
初级完成 (实际的)
2009年5月1日
研究完成 (实际的)
2009年5月1日
研究注册日期
首次提交
2010年4月13日
首先提交符合 QC 标准的
2010年4月13日
首次发布 (估计)
2010年4月15日
研究记录更新
最后更新发布 (实际的)
2019年8月8日
上次提交的符合 QC 标准的更新
2019年6月24日
最后验证
2019年6月1日
更多信息
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.
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