A Phase I, Open-label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Subjects With Normal Renal Function and Subjects With Various Degrees of Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- Maximum Observed Serum Concentration (Cmax) of Olpasiran
研究概览
简要总结
The primary objective of this study is to evaluate the pharmacokinetics (PK) of a single dose of olpasiran in participants with normal renal function and participants with various 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
- Basic Science
- 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
Single Dose Olpasiran Renal Impairment
Participants will be enrolled in 1 of 5 renal function groups based on their renal impairment status, as determined by estimated glomerular filtration rate (eGFR). All participants will receive a single dose of olpasiran on Day 1.
干预措施: Olpasiran (Drug)
Single Dose Olpasiran Normal Renal Function
Participants with normal renal function will be enrolled and will receive a single dose of olpasiran on Day 1.
干预措施: Olpasiran (Drug)
结局指标
主要结局
Maximum Observed Serum Concentration (Cmax) of Olpasiran
时间窗: Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29
Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Olpasiran
时间窗: Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Olpasiran
时间窗: Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29
Dialysis Clearance of Drug From Plasma (CLD) of Olpasiran
时间窗: Pre-Dialysis, 0.5, 1, 3 hours after the start of Dialysis, and immediately following the end of Dialysis, Day 1, Day 4
次要结局
- Time to Reach Imax of Lp(a)(Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85)
- Maximum Inhibitory Effect (Imax) of Plasma Lp(a)(Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85)
- Area Under the Effect Time Curve (AUEC) of Plasma Lipoprotein a (Lp[a])(Screening, Day 1, Day 2, Day 4, Day 7, Day 15, Day 29, Day 57, and Day 85)
- Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Measurements(Up to Day 85)
- Number of Participants Who Experience an Adverse Event (AE)(Up to Day 85)
- Number of Participants with Clinically Significant Changes in Clinical Laboratory Evaluations(Up to Day 85)
- Number of Participants with Clinically Significant Changes in Vital Signs(Up to Day 85)