An Open-label, Two Period Study to Determine the Excretion Balance and Pharmacokinetics of [14C]-GSK221149A, Administered as Single Doses of an Oral Solution and an Intravenous Infusion to Healthy Female Volunteers

GlaxoSmithKline2 个研究点分布在 1 个国家目标入组 6 人开始时间: 2006年10月1日最近更新: 2012年3月19日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: GlaxoSmithKline
入组人数: 6
试验地点: 2
主要终点: Urinary and fecal cumulative excretion as a percentage of the total radioactive dose administered over time. Collection of plasma, urine and fecal samples for assessment of metabolites. Samples are collected for approximately 7 days (or longer).

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 phase one study investigating the absorption, distribution, metabolism and excretion of GSK221149A in six healthy women of non-child bearing potential.

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: None

入排标准

年龄范围: 30 Years 至 55 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Healthy adult, non-smoking females
•Aged between 30 - 55 years old, and BMI of between 19 and 32
•Not of child-bearing potential

排除标准

•No clinically significant findings on clinical examination, medical examination and blood tests.
•Radiation exposure over previous 3 years is greater than 10mSv
•History of bleeding or gastric problems

结局指标

主要结局

Urinary and fecal cumulative excretion as a percentage of the total radioactive dose administered over time. Collection of plasma, urine and fecal samples for assessment of metabolites. Samples are collected for approximately 7 days (or longer).

次要结局

Clinical Safety data. PK parameters of GSK221149A and drug-related material (radioactivity) in plasma following oral and intravenous dosing. Samples are collected for approximately seven days (or longer) following dosing.

研究者

发起方

GlaxoSmithKline

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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