An Open-Label, Single-dose, Pharmacokinetic, Pharmacodynamic, and Safety Study of PEGylated Interferon Beta-1a (BIIB017) in Healthy Subjects and Subjects With Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 35
- 主要终点
- Area under the time-concentration curve (AUC) for serum concentrations of peginterferon beta-1a
研究概览
简要总结
The primary objective of the study is to evaluate the pharmacokinetics (PK) of a single dose of PEGylated Interferon Beta-1a (BIIB017) administered subcutaneous in participants with renal impairment and in participants with normal renal function (healthy participants). A secondary objective of this study in this study population is to evaluate the safety and tolerability of a single dose of PEGylated Interferon Beta-1a administered subcutaneous.
详细描述
This study is an open-label, multicenter, non-randomized, serial-group study to estimate the effect of renal impairment on BIIB017 PK/PD. The study will be conducted at approximately 3 sites in the US and will enroll approximately 35 participants: 6 healthy volunteers (normal renal function), 9 with mild renal impairment, 6 with moderate renal impairment, 8 with severe renal impairment, and 6 participants with end stage renal disease who require hemodialysis 2 to 3 times a week.
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
- •Subjects must have stable renal disease (i.e., no change in disease status within the last month) as determined by the Investigator with laboratory and clinical findings that support the diagnosis of renal impairment.
- •Must have body mass index (BMI) between 18 and 35 kg/m2 inclusive.
排除标准
- •History of any clinically unstable (in the past 6 months prior to screening) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, and psychiatric, or other major disease as determined by the Investigator.
- •Any evidence of clinically significant findings on screening evaluations, which, in the opinion of the Investigator would pose a safety risk, or would interfere with appropriate interpretation of safety or PK data, or other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment
- •NOTE: Other protocol defined Inclusion/Exclusion Criteria May Apply
研究组 & 干预措施
peginterferon beta-1a
Single dose of peginterferon beta-1a at either 63 or 125 mcg in renal impaired Participants and healthy volunteers
干预措施: BIIB017(peginterferon beta-1a) (Drug)
结局指标
主要结局
Area under the time-concentration curve (AUC) for serum concentrations of peginterferon beta-1a
时间窗: Post-hemodialysis, pre-dose on Day 1, post dose at 6, 12, 24, 36, 48, 72, 96, 168, 240, 336, 408, 504, 576 and 672 hours
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Day 1 up to Week 5)