临床试验/NCT00474552

NCT00474552终止1 期

An Ascending Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 Administered Orally to Healthy Young Adult and Elderly Subjects

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 56 人开始时间: 2007年6月最近更新: 2008年2月18日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方
入组人数: 56
主要终点: safety, tolerability and PK

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Primary: To assess the safety and tolerability of ascending multiple oral doses of SAM-315, an investigational drug, in healthy young adult and elderly subjects.

Secondary: To assess the Pharmacokinetic and Pharmacodynamic profiles of multiple oral doses of SAM-315 in healthy young adult and elderly subjects.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: Double (Participant, 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

•Young healthy subjects:
•Men and women of nonchildbearing potential (WONCBP) aged 18 to 45 years inclusive on study day
•Body mass index (BMI) in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg and body weight greater than or equal to 50 kg.
•Elderly Healthy subjects:
•Men or women aged 65 years and above as of study day
•BMI in the range of 18 to 30 kg/m2 and body weight greater than or equal to 45 kg and body weight greater than or equal to 45 kg.

排除标准

•Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
•History of any clinically important drug allergy.

研究组 & 干预措施

1

Experimental

Experimental-Placebo Comparator

干预措施: SAM-315 (Drug)

结局指标

主要结局

safety, tolerability and PK

时间窗: 10 months

次要结局

未报告次要终点

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

相似试验

已完成

1 期

Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531Alzheimer Disease

NCT00479349Wyeth is now a wholly owned subsidiary of Pfizer32

已完成

1 期

Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Young and Elderly SubjectsAlzheimer Disease

NCT00480818Wyeth is now a wholly owned subsidiary of Pfizer80

已完成

1 期

Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-315 in Healthy AdultsAlzheimer Disease

NCT00479440Wyeth is now a wholly owned subsidiary of Pfizer56

已完成

1 期

Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 in Healthy Japanese MalesAlzheimer Disease

NCT00480467Wyeth is now a wholly owned subsidiary of Pfizer32

已完成

1 期

Study Evaluating the Pharmacokinetics of HCV-796 in Healthy Japanese MenHealthy

NCT00385190Wyeth is now a wholly owned subsidiary of Pfizer24