NCT00831532已完成1 期
A Phase 1, Non-Randomized, Open-Label, Single-Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [Pf-01913539] In Subjects With Hepatic Impairment And Normal Hepatic Function
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (AUC and Cmax)
研究概览
简要总结
- To compare the pharmacokinetics of Dimebon in subjects with mild and moderate hepatic impairment to subjects with normal hepatic function.
- To assess the safety and tolerability of Dimebon in subjects with hepatic impairment and subjects with normal hepatic function.
- To explore the pharmacokinetics of Dimebon in subjects with severely-impaired hepatic function.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy (healthy is defined as the absence of clinically-relevant abnormalities identified by a detailed medical history, full physical examination, 12-lead ECG and clinical laboratory tests).
- •Free of any medical or surgical conditions that might significantly interfere with gastrointestinal absorption, distribution, metabolism, or excretion of Dimebon.
- •Demographically comparable to subjects with mild and moderate hepatic impairment.
- •Subjects with hepatic impairment: Screening medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests performed within 28 days before the first dose of study medication, abnormal findings that are related to the subject's underlying condition are acceptable.
- •Satisfy the criteria for Class A, B, or C of the modified Child-Pugh classification [Mild (Child-Pugh Scores 5-6 points), moderate (Child-Pugh Scores 7-9 points), and severe (Child-Pugh Scores >9 and <12 points)] within 14 days before the first dose of study medication.
- •A diagnosis of hepatic impairment due to cirrhosis, not secondary to other diseases, which is confirmed and documented by medical history, physical examination, liver biopsy or hepatic ultrasound, CT scan or MRI.
排除标准
- •Subjects presenting with any of the following will not be included in the trial:CYP2D6 PM genotype, as identified by screening genotyping.
- •A known sensitivity to Dimebon.
- •Exposure within the previous three months to a drug known to have a negative effect on skeletal muscle or reproductive organs.
- •History of febrile illness within 5 days prior to the first dose.
- •Any condition possibly affecting drug absorption (e.g., gastrectomy, active peptic ulcer within last 3 months).
研究组 & 干预措施
Normal
Experimental
Healthy Volunteers
干预措施: Dimebon (Drug)
Mild Hepatic Impairment
Experimental
Mild hepatic impairment patients
干预措施: Dimebon (Drug)
Moderate hepatic Impairment
Experimental
Moderate Hepatic Impairment Patients
干预措施: Dimebon (Drug)
Severe Hepatic Impairment
Experimental
Severe Hepatic Impairment Patients
干预措施: Dimebon (Drug)
结局指标
主要结局
Pharmacokinetics (AUC and Cmax)
时间窗: 1 day
次要结局
- Safety (AEs, labs, ECG, vitals)(1 day)
研究者
研究点 (1)
Loading locations...
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