NCT00825084已完成1 期
A Phase 1, Randomized, Subject- And Investigator-Blind, Sponsor-Open, Placebo-Controlled, Parallel-Cohort, Single-Dose Escalation, And Multiple-Dose Titration Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy 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
- 45
- 试验地点
- 1
- 主要终点
- plasma drug concentrations
研究概览
简要总结
This study is to characterize the pharmacokinetics of single and multiple oral doses of Dimebon in Japanese healthy subjects. This study is also to evaluate the safety and tolerability of single and multiple oral doses of Dimebon in Japanese healthy subjects. The secondary objective of this study is to compare the pharmacokinetics, safety and tolerability of single and multiple oral doses of Dimebon in Japanese and Western healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG, and clinical laboratory tests).
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight within the range of 50 to 100 kg.
- •An informed consent document signed and dated by the subject or a legally-acceptable representative.
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Japanese subjects must have four Japanese grandparents who were born in Japan.
排除标准
- •Asian or Polynesian subjects in Western subject groups.
- •Any condition possibly affecting drug absorption (e.g., gastrectomy, active peptic ulcer within last 3 months).
- •History of regular alcohol consumption exceeding an average of 7 drinks/week for females and 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
- •Subjects who, by history, smoke more than 5 cigarettes per day.
- •Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
- •12-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450 msec, the ECG may be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.
- •Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication.
- •Use of prescription or nonprescription drugs, vitamins and dietary supplements, within 7 days or 5 half-lives (whichever is longer) of the first dose of study medication. Herbal supplements and hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) and hormone replacement therapy must be discontinued 28 days prior to the first dose of study medication. Depo-Provera® must be discontinued at least 6 months prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of ≤ 2 grams/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.
研究组 & 干预措施
single dose cohort-Japanese group
Experimental
Japanese healthy subjects
干预措施: Dimebon (Drug)
single dose cohort-Western group
Experimental
Western healthy subjects
干预措施: Dimebon (Drug)
multiple dose cohort-Japanese group
Experimental
Japanese healthy subjects
干预措施: Dimebon (Drug)
multiple dose cohort-Western group
Experimental
Western healthy subjects
干预措施: Dimebon (Drug)
结局指标
主要结局
plasma drug concentrations
时间窗: 72 hours post last dose
次要结局
- Safety will be including physical/neurological examination findings, clinical safety laboratory assessments, 12-lead ECGs, vital sign measurements and adverse event monitoring(72 hours post last dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Phase 1 Trial To Assess The Safety And Pharmacokinetics Of Single, Ascending, Oral Doses Of Dimebon In Healthy AdultsHealthy VolunteersNCT00907322Pfizer12
已完成
2 期
A Study of the Novel Drug Dimebon in Patients With Huntington's DiseaseHuntington's DiseaseNCT00497159Medivation, Inc.91
已完成
1 期
A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of DextromethorphanAlzheimer DiseaseHuntington DiseaseNCT00788047Pfizer14
已完成
1 期
Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691Hepatitis C VirusNCT00810758Pfizer24
已完成
2 期
Double-blind, Placebo-controlled Study of Oral Dimebon in Subjects With Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT00377715Medivation, Inc.183