NCT00449709终止1 期
A Two-part, Open-label, Cross-over Study to Assess the Pharmacokinetics of GSK221149 Following Single Oral Doses of Various Modified Release Formulations and a Solution in Healthy Adult Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Blood samples will be drawn and analyzed to assess how the body handles the drug over a 24 hour period during each study session.
研究概览
简要总结
PreTerm Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. GSK221149 is an experimental drug that will be used to block the effects of oxytocin, and therefore pause or prevent contractions. In this study, the pharmacokinetics of various modified release formulations of GSK221149 will be investigated in healthy non-pregnant adult subjects.
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and non-pregnant female
- •Between the ages of 18 and 50 years old.
- •Females may be of child-bearing or non-child-bearing potential.
- •Non-smokers
- •BMI of between 19 and 30 kg/m2 (weight of greater than 110lbs).
排除标准
- •History of smoking within past 6 months
- •Regular alcohol consumption averaging 7 drinks or more per week
- •Subject is positive for hepatitis C antibody, hepatitis B surface antigen, or HIV
- •Use of prescription or non-prescription drugs within 14 days of study start
结局指标
主要结局
Blood samples will be drawn and analyzed to assess how the body handles the drug over a 24 hour period during each study session.
时间窗: over a 24 hour period during each study session.
次要结局
- Safety and tolerability will be assessed by blood pressure, ECGs, and blood sampling over a 24 hour time period during each study session..(over a 24 hour period during each study session.)
研究者
研究点 (2)
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