An Open-Label, Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KBP-5074 in Healthy Subjects With a Separate Panel in Subjects With Mild to Moderate Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
This multiple ascending dose (MAD) study in healthy subjects and subjects with mild to moderate renal impairment will evaluate the safety, tolerability and pharmacokinetics of KBP-5074. Safety/tolerability data and Pharmacokinetics (PK)/Pharmacodynamics (PD) (plasma aldosterone, serum potassium, UACR and Blood Pressure) relationships will be explored to support the selection of dosing regimens of KBP-5074 that are suitable for the Phase II/III study.
详细描述
This study consists of two parts: Part 1 is an open-label, multiple ascending dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of KBP-5074 in healthy subjects. The safety and tolerability will be assessed at each dose level before progressing to the next higher dose. Part 2 is an open label, randomized, parallel study to assess the safety and tolerability, the effect of renal dysfunction on the pharmacokinetics of KBP-5074, as well as the PK/PD relationship in subjects with mild to moderate 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 75 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
Cohort 1
Healthy Volunteers will receive 2.5mg of KBP-5074, QD, 14 days
干预措施: KBP-5074 (Drug)
Cohort 2
Healthy Volunteers will receive 5.0mg of KBP-5074, QD, 14 days
干预措施: KBP-5074 (Drug)
Cohort 3
Subjects with mild to moderate renal impairment will receive 0.5mg of KBP-5074, QD, 56 days
干预措施: KBP-5074 (Drug)
Cohort 4
Subjects with mild to moderate renal impairment will receive 2.5mg of KBP-5074, QD, 56 days
干预措施: KBP-5074 (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: Up to 69 days
Rate of adverse events
次要结局
- Area Under Curve (AUC) in healthy subjects(pre-dose and 2, 4, 6, 8, 10, 12, 18, and 24 hours post dose on Day 1; pre-dose on Days 8, 11, 12, and 13; and pre-dose and 2, 4, 6, 8, 10, 12, 18, 24, 48, 72, 96, 120, 168, 216, 264, and 312 hours post dose on Day 14)
- Area Under Curve (AUC) in subjects with mild to moderate renal impairment(pre-dose and 2, 4, 6, 8, 10, 12, 18, and 24 hours post dose on Day 1; pre-dose on Days 8, 11, 12, and 13; pre-dose and 2, 4, 6, 8, 10, 12, 18, and 24 hours post dose on Day 14; pre-dose on Days 29 and 43; and pre-dose and 6, 12, and 24 hours on Day 56)
- The effect of mild to moderate renal impairment on the Area Under Curve (AUC)(Up to 15 days)
- Plasma aldosterone levels in healthy subjects(Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Day 8; and 24 hours post last dose on Day 15)
- Serum potassium levels in healthy subjects(Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Day 8; and 24 hours post last dose on Day 15)
- Plasma aldosterone levels in subjects with mild to moderate renal impairment(Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Days 8, 15, 29, and 43; and 24 hours post last dose on Day 57)
- Serum potassium levels in subjects with mild to moderate renal impairment(Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Days 8, 15, 29, and 43; and 24 hours post last dose on Day 57)
- Urinary Albumin to Creatinine Ratio (UACR) in subjects with mild to moderate renal impairment(Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Days 8, 15, 29, and 43; and 24 hours post last dose on Day 57)
- Blood Pressure in subjects with mild to moderate renal impairment(Pre-dose, 6, and 24 hours post dose on Day 1; pre-dose on Days 8, 15, 29, and 43; and 24 hours post last dose on Day 57)