Single and Repeat Dose Pharmacokinetic Study of GSK1605786 in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This is an open-label, parallel group, single and repeat dose pharmacokinetic (PK) study in healthy male and female subjects. This study will confirm the PK and safety profile in Chinese subjects. GSK1605786 is currently in clinical development for the treatment of Crohn's disease. Subjects will receive one of two GSK1605786 doses (500 mg once daily or 500mg twice daily) within 30 minutes after a meal. The study will consist of single and repeat dose sessions, with pre-dose and serial PK samples taken up to 72-h post-dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG
- •Male or female between 18 and 45 years of age
- •Body weight 50 kg (110lbs) for men and women, and body mass index (BMI) within the range 19 24 kg/m2
排除标准
- •A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- •Current or chronic history of liver disease, or known hepatic or biliary
- •A positive test for HIV antibody at screening
- •Known coeliac disease and positive serologic testing for anti-tTG antibodies
- •A positive pre-study drug/alcohol screen
- •Lactating females
研究组 & 干预措施
GSK1605786 500 mg once daily
GSK1605786 500 mg is given once daily in the morning
干预措施: GSK1605786 capsule (Drug)
GSK1605786 500 mg twice daily
GSK1605786 500 mg is given twice daily in the morning and in the evening
干预措施: GSK1605786 capsule (Drug)
结局指标
主要结局
Cmax
时间窗: up to 72 hour post dose
maximum concentration after single dose and repeat dose
AUC(0-τ)
时间窗: up to 24 hour post last dose
area under the concentration time curve during steady state
次要结局
- lab assessment(Day 17 prior to leaving the clinic)
- adverse events (AEs)(up to 21 days, from the first dose until the follow-up visit)
- vital signs(before each morning dose on Day 1 and 8-14, and on Day 17 prior to leaving the clinic)