Phase 1, Open-label, Single-dose Study of Evolocumab (AMG 145) Administered Subcutaneously to Subjects With Normal Renal Function or Severe Renal Impairment or End Stage Renal Disease Receiving Hemodialysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum Observed Serum Concentration (Cmax) of Evolocumab
研究概览
简要总结
The primary objective of this study was to evaluate the pharmacokinetics of evolocumab after a single 140 mg subcutaneous (SC) dose in aduts with normal renal function or severe renal impairment or end-stage renal disease (ESRD) receiving hemodialysis.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) of ≥ 18 and ≤ 35 kg/m² at screening.
- •Subjects will have low-density lipoprotein cholesterol (LDL-C) of 70-190 mg/dL (inclusive) and on statin therapy.
- •Other inclusion criteria may apply.
排除标准
- •Subject with current or prior history of statin intolerance
- •Subject has previously received Evolocumab (AMG 145) or any other investigational therapy directed against PCSK9
- •Known substance abuse (eg, alcohol, licit or illicit drugs) within 12 months of day -1
- •Testing positive for alcohol and/or drugs-of-abuse at screening, day -1, or day 1 (alcohol only)
- •History of hypersensitivity or allergic reaction to mammalian-derived drug preparations
- •Known sensitivity to any of the active substances or their excipients to be administered during dosing, eg, carboxymethylcellulose
- •Other exclusion criteria may apply.
研究组 & 干预措施
Evolocumab
Participants received a single 140 mg dose of evolocumab subcutaneously on Day 1.
干预措施: Evolocumab (Biological)
结局指标
主要结局
Maximum Observed Serum Concentration (Cmax) of Evolocumab
时间窗: Predose and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose
Serum concentrations of evolocumab were measured by a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification (LLOQ) of the assay was 800 ng/mL.
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC0-last) for Evolocumab
时间窗: Predose and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose
次要结局
- Number of Participants With Clinically Relevant Vital Sign or Clinical Laboratory Changes(57 days)
- Number of Participants With Adverse Events(From the first dose of study drug up until Day 57)
- Mean Percent Change From Baseline in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9)(Baseline and 4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose)
- Number of Participants With Anti-evolocumab Antibodies(57 days)
- Area Under the Effect Curve From Baseline to Day 57 (AUECday1-57) for Low-density Lipoprotein Cholesterol (LDL-C)(4 hours, 2, 3, 4, 6, 8, 11, 15, 22, 29, 43, 50 and 57 days postdose)