NCT00427141已完成1 期
A Three-part First Time in Human Study to Evaluate Safety, Tolerability, Pharmacokinetics and Food Effect of Single Oral Doses of GSK580416 in Healthy Adult Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Safety assessments (adverse event, ECG and vital sign) will be performed during the study. Blood samples to determine drug levels in the body will be collected during the study.
研究概览
简要总结
Studies for GSK580416 have been completed in rats and dogs. The main toxic effects seen in animals affected the digestive system and blood cells. Study OPS106400 will be the first administration of GSK580416 in humans. Parts A and B of this study will examine the safety, tolerability, and pharmacokinetics of increasing single doses of GSK580416 with reference to placebo. Part C of the study will assess the effect of food on the safety, tolerability, and pharmacokinetics of a single dose of GSK580416 in healthy 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
- Single
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy as determined by a physician
- •Healthy male or female of non-child bearing potential between 18 and 55 years of age (inclusive)
- •Body weight > = 50 kg and BMI between 19 and 30 kg/m2 (inclusive)
排除标准
- •Positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody with 3 months of screening
- •Male and female subjects not willing to follow study specified contraceptive methods
- •Subjects taking any recreational drugs
- •Regular use of tobacco- or nicotine-containing products within 6 months prior to screening
- •Has participated in a clinical trial and have not received a drug within 30 days before the dose of study drug
- •Has exposed to more than 4 new chemical entities within 12 months before the first dosing day
- •Use of prescription or over-the-counter medications within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
- •Use of St. John's Wort within 28 days before the first dose of study drug
- •Subjects not willing to follow study specified life style restrictions
- •Blood donation in excess of 500 mL within a 56 days period
结局指标
主要结局
Safety assessments (adverse event, ECG and vital sign) will be performed during the study. Blood samples to determine drug levels in the body will be collected during the study.
时间窗: during the study
次要结局
- Blood samples to determine drug levels in the body will be collected during the study.(during the study)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A First Time In Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GSK1399686Inflammatory Bowel DiseasesNCT00721812GlaxoSmithKline87
已完成
1 期
First Time in Human StudyDepressive Disorder and Anxiety DisordersNCT01031186GlaxoSmithKline20
已完成
1 期
First Study in Humans With GSK206136Depressive Disorder and Anxiety DisordersNCT01059578GlaxoSmithKline33
已完成
2 期
To Investigate the Safety, Tolerability and Pharmacodynamics of GSK2890457 in Healthy Volunteers and Subjects With Type 2 DiabetesObesityNCT01725126GlaxoSmithKline53
已完成
1 期
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Experimental Rabies Vaccine in Healthy AdultsVirus DiseasesNCT04062669GlaxoSmithKline160