A Phase I Study to Evaluate the Pharmacokinetics of MK-7145 Following Single Dose Administration in Patients With Moderate Renal Insufficiency
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Area Under the Plasma-Time Curve From 0 to Infinity (AUC0-∞) of MK-7145 2 mg IR Following Single Dose Administration
研究概览
简要总结
The primary purpose of this study is to obtain a preliminary pharmacokinetic profile of MK-7145 2 mg immediate release (IR) following single-dose administration in male participants with moderate renal insufficiency. In addition, the study will evaluate the pharmacodynamic effect of a single dose of MK-7145 2 mg IR on 24-hour net natriuresis in male participants with moderate renal insufficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) 18 to 35 kg/m^2
- •Nonsmoker and/or have not used nicotine or nicotine-containing products
- •for at least 3 months prior to enrollment
- •Estimated glomerular filtration rate (eGFR) 30 to 60 mL/min/1.73 m^2
排除标准
- •History of stroke, chronic seizures, or major neurological disorder
- •Ongoing, clinically significant endocrine, gastrointestinal, cardiovascular,
- •hematological, hepatic, immunological, respiratory, or genitourinary abnormalities or diseases
- •Systolic blood pressure (SBP) ≤95 mmHg or >160 mmHg, or diastolic blood
- •pressure (DBP) ≤45 mmHg or >95 mmHg
- •History of neoplastic disease except for adequately treated non-melanomatous skin carcinoma
- •Unable to refrain from, or anticipates the use of, strong/moderate cytochrome P450 3A4 (CYP3A4) inhibitors
- •Consumes excessive amounts of alcohol, defined as greater than 3 glasses of alcoholic beverages, wine, or distilled spirits per day
- •Consumes excessive amounts of caffeine, defined as greater than 6 servings of coffee, tea, cola, or other caffeinated beverages per day
- •Had major surgery or donated blood within 8 weeks prior to enrollment
- •Has participated in another investigational study within 4 weeks prior
- •History of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food
- •Currently a regular user of illicit drugs, or has a history of drug (including alcohol) abuse within approximately 6 months
- •Has active or has a history of nephrolithiasis
- •Has had a kidney removed or has a functioning renal transplant
研究组 & 干预措施
MK-7145
MK-7145 2 mg IR administered as a single oral dose.
干预措施: MK-7145 (Drug)
结局指标
主要结局
Area Under the Plasma-Time Curve From 0 to Infinity (AUC0-∞) of MK-7145 2 mg IR Following Single Dose Administration
时间窗: Up to 48 Hours Post Dose
Maximum Plasma Concentration (Cmax) of MK-7145 2 mg IR Following Single Dose Administration
时间窗: Up to 48 Hours Post Dose
Time to Maximum Plasma Concentration (Tmax) of MK-7145 2 mg IR Following Single Dose Administration
时间窗: Up to 48 Hours Post Dose
Apparent Half-Life (t 1/2) of MK-7145 2 mg IR Following Single Dose Administration
时间窗: Up to 48 Hours Post Dose
Oral Clearance (CL/F) of MK-7145 2 mg IR Following Single Dose Administration
时间窗: Up to 24 Hours Post Dose
Oral Volume of Distribution (V/F) of MK-7145 2 mg IR Following Single Dose Administration
时间窗: Up to 48 Hours Post Dose
次要结局
- Change From Baseline in 24-Hr Urine Natriuresis (UNa0-24)(24 Hours Prior to Dosing (Baseline) and Up to 24 Hours Post Dose)