A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Subjects With Renal Insufficiency
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 32
- 主要终点
- Plasma Area Under the Curve (AUC [0-infinity]) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls
研究概览
简要总结
This study will assess the pharmacokinetics of MK-0941 in participants with varying degrees of renal insufficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Male or nonpregnant female age 18 to 75 years
- •Female of childbearing potential on appropriate method of contraception
- •Body mass index (BMI) less than or equal to 40 kg/m2
- •Participant is in good health
- •Participant diagnosed with Type 2 Diabetes
- •Participant agrees to follow smoking restrictions
- •Willing to follow the study diet restrictions
排除标准
- •Mental or legal incapacitation
- •Participant has had kidney removed
- •History of Type 1 diabetes
- •History of stroke, chronic seizures or major neurological disorder
- •History of neoplastic disease
- •Nursing mother
- •Consumes greater than 4 glasses of alcoholic beverages per day
- •Consumes greater than 6 servings of caffeinated beverages per day
- •Participant has had surgery or donated 1 unit of blood within 1 month of screening
- •Participant has history of recent eye infection within 2 weeks of study drug administration
- •Clinically diagnosed with glaucoma or blindness
- •Has trauma to one or both eyes
研究组 & 干预措施
MK-0941 20 mg Mild Renal Insufficiency
MK-0941 20 mg administered to participants with mild renal insufficiency and type 2 diabetes.
干预措施: MK-0941 20 mg (Drug)
MK-0941 20 mg Moderate Renal Insufficiency
MK-0941 20 mg administered to participants with moderate renal insufficiency and type 2 diabetes.
干预措施: MK-0941 20 mg (Drug)
MK-0941 5 mg Severe Renal Insufficiency
MK-0941 5 mg administered to participants with severe renal insufficiency and type 2 diabetes.
干预措施: MK-0941 5 mg (Drug)
MK-0941 20 mg Matched Controls
MK-0941 20 mg administered to age-, gender-, race-, body mass index (BMI)-, and hemoglobin A1C (HbAIc)-matched control subjects with normal renal function and type 2 diabetes.
干预措施: MK-0941 20 mg (Drug)
MK-0941 5 mg Matched Controls
MK-0941 5 mg administered to age-, gender-, race-, body mass index (BMI)-, and HbAIc-matched control subjects with normal renal function and type 2 diabetes.
干预措施: MK-0941 5 mg (Drug)
结局指标
主要结局
Plasma Area Under the Curve (AUC [0-infinity]) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls
时间窗: 72 Hours Post-Dose
Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and mild renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Mild renal insufficiency was defined as a 24-hour creatinine clearance (CLCR) of \> 50 to 80 mL/min/1.73m\^2.
Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among With Moderate Renal Insufficiency vs Matched Controls
时间窗: 72-Hours Post-Dose
Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and moderate renal insufficiency taking a single oral dose of 20 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 20 mg of MK-0941. Moderate renal insufficiency was defined as a 24-hour CLCR of 30 to 50 mL/min/1.73m\^2.
Plasma AUC (0-infinity) After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls
时间窗: 72-Hours Post-Dose
Plasma AUC (0-infinity) was evaluated among participants with Type 2 Diabetes Mellitus (T2DM) and severe renal insufficiency taking a single oral dose of 5 mg of MK-0941 versus controls with normal renal function taking a single oral dose of 5 mg of MK-0941. Severe renal insufficiency was defined as a 24-hour CLCR of \> 30 mL/min/1.73m\^2.
次要结局
- Tmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls(72-Hours Post-Dose)
- Maximum Plasma Concentration (Cmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls(72-Hours Post-Dose)
- Cmax After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls(72-Hours Post-Dose)
- T 1/2 After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency vs Matched Controls(72-Hours Post-Dose)
- Amount of MK-0941 Excreted Unchanged in the Urine (Fe) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency Versus Matched Controls(36-Hours Post-Dose)
- Cmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls(72-Hours Post-Dose)
- Time to Apparent Half Life (T 1/2) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls(72-Hours Post-Dose)
- T 1/2 After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls(72-Hours Post-Dose)
- Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls(Up to 12 Hours Post-Dose)
- Plasma Glucose Concentration After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls(Up to 12 Hours Post-Dose)
- Time to Maximum Plasma Concentration (Tmax) After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Mild Renal Insufficiency vs Matched Controls(72-Hours Post-Dose)
- Tmax After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency vs Matched Controls(72-Hours Post-Dose)
- Fe After Administration of a Single Oral Dose of 20 mg of MK-0941 Among Participants With Moderate Renal Insufficiency Versus Matched Controls(36-Hours Post-Dose)
- Fe After Administration of a Single Oral Dose of 5 mg of MK-0941 Among Participants With Severe Renal Insufficiency Versus Matched Controls(36-Hours Post-Dose)
- CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls(36-Hours Post-Dose)
- CLCR After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Moderate Renal Insufficiency Versus Matched Controls(36-Hours Post-Dose)
- CLCR After Administration of a Single Oral Dose of 5 mg of MK-0941 to Participants With Severe Renal Insufficiency Versus Matched Controls(36-Hours Post-Dose)
- Plasma Glucose Concentration After Administration of a Single Oral Dose of 20 mg of MK-0941 to Participants With Mild Renal Insufficiency Versus Matched Controls(Up to 12 Hours Post-Dose)