Ascending Single Dose Study Of The Safety, Tolerability And Pharmacokinetics Of SAM-760 Administered Orally To Healthy Young And Healthy Elderly Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability.
研究概览
简要总结
This study will assess the safety and tolerability of ascending single oral doses of SAM-760 in healthy young adult and healthy elderly subjects. The secondary objectives are to provide the concentrations of SAM-760 in the blood and to evaluate the effect of a high-fat meal on the concentrations in the blood of SAM-760 administered to healthy young adult subjects, and to evaluate the effects of concomitant administration of ketoconazole on the safety and the concentrations of SAM-760 in the blood of a single dose of SAM-760 in healthy young adult 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women of non-childbearing potential aged 18 to 50 years inclusive (healthy young subjects) and > 65 years (healthy elderly subjects) at screening.
- •Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight >= 50 kg.
排除标准
- •Presence or history of any disorder that may prevent the successful completion of the study.
- •Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational drug or placebo.
研究组 & 干预措施
1
active arm/healthy young
干预措施: SAM-760 (Drug)
2
placebo arm
干预措施: Placebo of SAM-760 (Drug)
3
ketoconazole interaction evaluation
干预措施: ketoconazole (Drug)
结局指标
主要结局
Number of participants with adverse events as a measure of safety and tolerability.
时间窗: 5 days
次要结局
- Maximum concentration (Cmax) for PF-05212377 over time.(5 days)
- Measurement of Area Under the curve (AUC) for PF-05212377.(5 days)
- Time of maximum (Tmax) concentration of PF-05212377 in plasma.(5 days)
- Elimination half life (t1/2) of PF-05212377.(5 days)