NCT00443170已完成1 期
A Randomized, Blinded, Placebo-controlled Study to Investigate the Safety, and Pharmacokinetics of Single and Repeat Dose Escalation of the Oral YAK3/DYRK3 Inhibitor GSK626616AC in Healthy 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
- 90
- 试验地点
- 4
- 主要终点
- adverse events at end of each cohort
研究概览
简要总结
This is a first time in human study to investigate the safety of GSK626616AC given as oral single and repeat doses in healthy subjects. An additional group of subjects will be assessed to determine the effect of several drugs given at the same time as GSK626616.
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
- 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
- •Age 18 to 55 years healthy subjects
- •Hemoglobin values of 13.5-17.0 g/dL for males or 12.0-15.5 g/dL for females.
- •Females cannot be pregnant.
排除标准
- •Cannot have exposure to greater than 4 new chemical entities within 12 months.
- •Cannot have a clinical history of current alcohol, or illicit drug use which, in the judgment of the Investigator, would interfere with the subject's ability to comply with the dosing schedule.
- •Cannot have a history of regular use of tobacco- or nicotine-containing products within 3 months.
- •Must not have received a blood transfusion or had a donation of blood within 3 months prior to study entry.
- •Cannot use be taking prescription, non-prescription or illicit drugs.
结局指标
主要结局
adverse events at end of each cohort
时间窗: end of each cohort
hematology/chemistry/urinalysis at end of each cohort
时间窗: end of each cohort
physical examination at end of each cohort
时间窗: end of each cohort
vital signs and electrocardiogram (ECG) at end of each cohort
时间窗: end of each cohort
次要结局
- GSK626616 pharmacokinetics at end of each cohort(end of each cohort)
- hemoglobin at end of each cohort(end of each cohort)
- red blood cell measurements at end of each cohort(end of each cohort)
- estimates of CYP enzyme activity at end of study(end of study)
- mRNA levels in peripheral blood at end of study(end of study)
研究者
研究点 (4)
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