An Open-Label, Single-Dose Study to Investigate the Pharmacokinetics of MK-4618 in Patients With Renal Insufficiency
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Apparent Total Body Clearance (CL/F) After a Single Oral Dose of Vibegron 100 mg
研究概览
简要总结
This study will investigate the impact of impaired renal function on the plasma pharmacokinetics of vibegron (MK-4618) to guide use of vibegron in clinical trials in participants with overactive bladder and to guide recommendations on potential dosing adjustments for individuals with varying degrees of renal impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Participants With Severe Renal Insufficiency
Participants will receive a single oral dose of vibegron 100 mg on Day 1.
干预措施: Vibegron 100 mg (Drug)
Participants With Moderate Renal Insufficiency
Participants will receive a single oral dose of vibegron 100 mg on Day 1.
干预措施: Vibegron 100 mg (Drug)
Participants With Mild Renal Insufficiency
Participants will receive a single oral dose of vibegron 100 mg on Day 1.
干预措施: Vibegron 100 mg (Drug)
Healthy Matched Control Participants
Participants receive a single oral dose of vibegron 100 mg on Day 1.
干预措施: Vibegron 100 mg (Drug)
结局指标
主要结局
Apparent Total Body Clearance (CL/F) After a Single Oral Dose of Vibegron 100 mg
时间窗: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose
Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine CL/F after a single oral dose of vibegron 100 mg.
Area Under the Concentration-time Curve From 0 to Infinity (AUC0-∞) After a Single Oral Dose of Vibegron 100 mg
时间窗: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose
Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine AUC0-∞ after a single oral dose of vibegron 100 mg.
Maximum Plasma Concentration (Cmax) After a Single Oral Dose of Vibegron 100 mg
时间窗: Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours postdose
Blood samples were collected predose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 216, and 336 hours after dosing in order to determine Cmax after a single oral dose of vibegron 100 mg.
次要结局
未报告次要终点