NCT00907322已完成1 期
A Phase 1, Investigator- And Subject-Blind (Sponsor-Open), Randomized, Crossover, Placebo-Controlled Trial To Assess The Safety, Tolerability, And Pharmacokinetics Of Single, Ascending, Oral Doses Of Dimebon [PF-01913539] In Healthy Adult Subjects
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
- 12
- 试验地点
- 1
- 主要终点
- Physical/neurological examination findings, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements, and adverse event monitoring.
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of Dimebon following single ascending doses. A formal single ascending dose study of this nature has not been performed to date in the Dimebon development program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
- •Subjects who display the CYP2D6 extensive, intermediate, ultra-rapid, or poor metabolizer statuses.
排除标准
- •A known history of hypersensitivity or previous intolerance to Dimebon or other antihistamines.
- •Subjects with any previous history of seizures, convulsions, epilepsy, or significant head injury.
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
研究组 & 干预措施
Dimbeon 20 mg
Experimental
干预措施: Dimebon (Drug)
Dimebon 40 mg
Experimental
干预措施: Dimebon (Drug)
Dimebon 60 mg
Experimental
干预措施: Dimebon (Drug)
Placebo
Experimental
干预措施: Dimebon (Drug)
结局指标
主要结局
Physical/neurological examination findings, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements, and adverse event monitoring.
时间窗: July 2009
Pharmacokinetic parameters: Cmax, Tmax, AUClast, AUCinf, half-life, CL/F and Vz/F.
时间窗: July 2009
次要结局
- Pharmacodynamics: results of a Drug Effect Questionnaire(once each arm)
研究者
研究点 (1)
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