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临床试验/NCT00501930
NCT00501930已完成1 期

A Randomized, Placebo-Controlled, Double-Blind, Repeat Dose, Dose Escalation Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Supratherapeutic Doses of GSK189075 Administered for 3 Days in Healthy Volunteers

GlaxoSmithKline2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2007年4月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
12
试验地点
2
主要终点
Clinical laboratory tests, ECGs, adverse events

研究概览

简要总结

This study will assess safety and tolerability when taking GSK189075 at doses that are likely to be higher than the expected prescribed doses. The study will also measure the level of GSK189075 in blood after dosing as well as the effect of the drug on certain laboratory tests performed on volunteer urine and blood. Each volunteer will take part in 3 dosing periods and will be given a different dose level at each period (either 2000mg, 4000mg, or a placebo). Volunteers will not know which of the three doses they are receiving. In each period, volunteers will dose every morning for three straight days. Before and after dosing, blood pressure, heart rate, laboratory tests on blood and urine, physical examinations and ECGs will be taken to assess safety. Volunteers will also be asked to provide information should they feel they are having a possible effect from the GSK189075. The levels of GSK189075 in the blood will be assessed by multiple blood draws, most of these will follow the third dose in each period. Depending on the results from the preceding periods, a fourth period may be added to the study to assess another dose level. The fourth period, if this is to occur, will be the same design as the other three periods, and the dose received will be less than 4000mg.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double

入排标准

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

入选标准

  • Healthy males and non-pregnant females as determined by a physician on the basis of medical history (including family history of heart disease), physical examination, and clinical laboratory tests.
  • written consent given
  • agreement to follow specific requirements of birth control during participation.

排除标准

  • history of drug or alcohol abuse within one year of the study screening.
  • use of tobacco or nicotine-containing products with 6 months prior to the study screening.
  • use of any prescription or non-prescription drugs, vitamins, herbal, and dietary supplements within 14 days of the start of the study.
  • blood donation within 56 days before the start of the study
  • receiving other investigational drugs or participating in other research trials within 30 days of the start of this study.

结局指标

主要结局

Clinical laboratory tests, ECGs, adverse events

时间窗: screening, Day -1 - 3 all periods, follow up

次要结局

  • blood plasma levels of GSK189075(Day 3)
  • clinical lab tests(each day)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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