A Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MK-8266 in Elderly Subjects With Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study. The hypothesis for this study is that single oral doses of MK-8266 selected for this study are sufficiently safe and well tolerated by elderly male and elderly female participants with hypertension to permit continued clinical investigation.
详细描述
Two panels, each consisting of eight participants (8 elderly males with mild to moderate hypertension in Panel A and 8 elderly females with mild to moderate hypertension in Panel B) will be randomized to receive either MK-8266 or matching placebo in a 3:1 ratio. Participants will receive single doses of MK-8266 or matching placebo in three treatment periods (Periods 1 through 3). In both Panel A and Panel B, doses will escalate in a rising, fixed sequence. In Period 1 (0.3 mg), Period 2 (0.6 mg), and Period 3 (0.7 mg and then 0.3 mg 10 hours later) once daily doses of MK-8266 or matching placebo will be administered.
All participants will receive at least 2 doses of MK-8266. Participants completing placebo treatment in Period 1 will flow to the MK-8266 arm in the next period, with 2 participants from the MK-8266 arm receiving placebo in the next period.
Blood samples will be obtained pre-dose and at selected time points up to 48 hours post-dose for determination of MK-8266 plasma concentrations.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Panel A MK-8266 0.3 mg (Elderly Males with Mild/Mod. HTN)
MK-8266 single dose 0.3 mg
干预措施: MK-8266 (Drug)
Panel A MK-8266 0.6 mg (Elderly Males with Mild/Mod. HTN)
MK-8266 single dose 0.6 mg
干预措施: MK-8266 (Drug)
Panel A MK-8266 0.7/0.3 mg (Elderly Males with Mild/Mod. HTN)
MK-8266 single dose 0.7 mg and then 0.3 mg after 10 hours
干预措施: MK-8266 (Drug)
Panel A Placebo to MK-8266 (Elderly Males with Mild/Mod. HTN)
Placebo to MK-8266 single dose
干预措施: Placebo (Drug)
Panel B MK-8266 0.3 mg (Elderly Females with Mild/Mod. HTN)
MK-8266 single dose 0.3 mg
干预措施: MK-8266 (Drug)
Panel B MK-8266 0.6 mg (Elderly Females with Mild/Mod. HTN)
MK-8266 single dose 0.6 mg
干预措施: MK-8266 (Drug)
Panel B MK-8266 0.7/0.3 mg (Elderly Fem. with Mild/Mod. HTN)
MK-8266 single dose 0.7 mg and then 0.3 mg after 10 hours
干预措施: MK-8266 (Drug)
Panel B Placebo to MK-8266 (Elderly Fem. with Mild/Mod. HTN)
Placebo to MK-8266 single dose
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Up to 48 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Number of Participants With Abnormal Laboratory Hematology Values Reported as an AE
时间窗: Up to 48 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Abnormal laboratory hematology value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory hematology value.
Number of Participants With Abnormal Laboratory Chemistry Values Reported as an AE
时间窗: Up to 48 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Abnormal laboratory chemistry value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory chemistry value.
Number of Participants With Abnormal Laboratory Urinalysis Values Reported as an AE
时间窗: Up to 37 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Abnormal laboratory urinalysis value was any AE reported under the System Organ Class of Investigations that was related to an abnormal laboratory urinalysis value.
Change From Baseline in Systolic Blood Pressure (SBP)
时间窗: Baseline and 0 to 8 hours postdose
Participants rested for at least 10 minutes prior to having vital sign measurements obtained.
Change From Baseline in Heart Rate
时间窗: Baseline and 0 to 8 hours postdose
Participants rested for at least 10 minutes prior to having vital sign measurements obtained. Heart rate measurements were obtained in the semirecumbent position and 3 sets of measurements were obtained approximately 1 minute apart.
Number of Participants With Abnormal Electrocardiograms (ECG) Reported as an AE
时间窗: Up to 48 days
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. An abnormal ECG value was any AE reported under the System Organ Classes of Investigations or Cardiac that was related to an abnormal ECG value.
次要结局
- MK-8266 PK Parameter Observed Time to Reach Cmax (Tmax)(Period 1, 2 and 3: Predose, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose.)
- The Time Weighted Average Systolic Blood Pressure (SBP) Evaluated Over 8 Hours Post Dose (TWA[0-8hrs]) Following a Single Oral Dose of MK-8266.(Up to 8 hours post dose in each dosing period (Up to 8 hours))
- MK-8266 Pharmacokinetic (PK) Parameter Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC[0-inf])(Period 1, 2 and 3: Predose, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose.)
- MK-8266 PK Parameter Apparent Half-Life (t1/2)(Period 1, 2 and 3: Predose, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose.)
- MK-8266 PK Parameter Observed Maximum (Peak) Plasma Concentration (Cmax)(Period 1, 2 and 3: Predose, 1.5, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours postdose.)