NCT00858156已完成1 期
An Open-Label, Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Oral BG9928 in Subjects With Mild and Moderate Hepatic Impairment and in Healthy Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- The comparative effect of hepatic function on the pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic impairment as compared to subjects with normal hepatic function
研究概览
简要总结
The primary objective of the study is to evaluate the effect of hepatic function on the pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic impairment and in subjects with normal hepatic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Must be between the ages of 18 and 75, inclusive.
- •Must have a Body Mass Index (BMI) between 19 kg/m2 and 36 kg/m2, inclusive.
- •The following criteria apply only to subjects enrolled into Groups 1 and 2 (mild or moderate hepatic impairment):
- •Must have stable hepatic disease (i.e., no change in disease status within the last 2 months as determined by the enrolling Investigator) with laboratory and clinical findings that support the diagnosis of hepatic impairment.
- •Must have a total Child-Pugh score (Section 22, Appendix I) of 5-6 (mild), or 7-9 (moderate).
- •Must be otherwise healthy as determined by the Investigator on the basis of pre-study physical examination, medical history, 12-lead ECG, vital signs, and clinical laboratory parameters. Subjects with controlled hypertension and those problems directly associated with the primary diagnosis of hepatic impairment may be included. Subjects with stable, mild, chronic concurrent diseases, such as degenerative joint disease, may be included.
排除标准
- •History of an allergic reaction to any methylxanthine-containing compound.
- •History of seizure within the past 10 years, or use of any medication for the suppression of seizures within the past 5 years.
- •History of brain surgery, meningitis/encephalitis, penetrating head trauma, stroke, or transient ischemic attack within the past 6 months.
- •History of active (within 6 months) drug or alcohol abuse, a positive drug screen (without a medically indicated rationale), or a positive alcohol breath test at Screening or on Day -
- •History of Human Immunodeficiency Virus (HIV) antibody.
- •Serious systemic infection (e.g., septicemia) within the 30 days prior to Day
- •Fever, with body temperature >38oC, within the 48 hours prior to Day
- •Active bacterial or viral infection.
结局指标
主要结局
The comparative effect of hepatic function on the pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic impairment as compared to subjects with normal hepatic function
时间窗: 1 week post dose
次要结局
未报告次要终点
研究者
研究点 (2)
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