Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SRA-444 Administered Orally to Healthy Adult Subjects

Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点分布在 1 个国家目标入组 64 人开始时间: 2007年2月1日最近更新: 2007年12月5日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 64
试验地点: 1
主要终点: Assessment of the safety and tolerability of SRA-444

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a first-in-humans study of SRA-444. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SRA-444 (SR formulation) after administration of ascending single oral doses to healthy adult 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

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy men or women of nonchildbearing potential aged 18 to 50 years,
•Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg.

排除标准

•Family history of sudden death and/or QT prolongation.
•An automatic ECG corrected QT (QTc) interval reading at screening >450 ms and >470 ms for male and female subjects, respectively.
•Sinus bradycardia at screening, defined as a resting heart rate ≤45 bpm. Resting supine blood pressure at screening <110 mm Hg (systolic) and/or <60 mm Hg (diastolic).

结局指标

主要结局

Assessment of the safety and tolerability of SRA-444

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

研究点 (1)

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