A Randomised, Single-Blind, Dose-Rising Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Ten Day Repeat Topical Applications of GW842470X Cream on the Skin of Patients With Atopic Dermatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Number of subjects with abnormal findings on lead II cardiac monitoring
研究概览
简要总结
The purpose of this study of this study is to investigate the safety, tolerability and pharmacokinetics of GW842470X in patients with atopic dermatitis. GW842470X is an inhibitor of phosphodiesterase 4 (PDE4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single dose 1 cohort
Subjects with body surface area (BSA) disease involvement between 10 and 15% will be included. Subjects will receive either 100 milligrams (mg) GW842470X or placebo in a ratio of 2:1.
干预措施: GW842470X (Drug)
Single dose 1 cohort
Subjects with body surface area (BSA) disease involvement between 10 and 15% will be included. Subjects will receive either 100 milligrams (mg) GW842470X or placebo in a ratio of 2:1.
干预措施: Placebo (Drug)
Repeat dose 1 cohort
Subjects with BSA disease involvement between 10 and 15% will be included. Subjects will receive either 100-150 mg GW842470X or placebo in a ratio of 3:1
干预措施: GW842470X (Drug)
Repeat dose 1 cohort
Subjects with BSA disease involvement between 10 and 15% will be included. Subjects will receive either 100-150 mg GW842470X or placebo in a ratio of 3:1
干预措施: Placebo (Drug)
Repeat dose 2 cohort
Subjects with BSA disease involvement between 30 and 40% will be included. Subjects will receive either 300-400 mg GW842470X or placebo in a ratio of 3:1
干预措施: GW842470X (Drug)
Repeat dose 2 cohort
Subjects with BSA disease involvement between 30 and 40% will be included. Subjects will receive either 300-400 mg GW842470X or placebo in a ratio of 3:1
干预措施: Placebo (Drug)
Repeat dose 3 cohort
Subjects with BSA disease involvement >=50% will be included. Subjects will receive either 500-1000 mg GW842470X or placebo in a ratio of 2:1
干预措施: GW842470X (Drug)
Repeat dose 3 cohort
Subjects with BSA disease involvement >=50% will be included. Subjects will receive either 500-1000 mg GW842470X or placebo in a ratio of 2:1
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with abnormal findings on lead II cardiac monitoring
时间窗: Up to Day 10
Number of subjects with abnormal clinical laboratory tests
时间窗: Up to Day 22
AUC
时间窗: Pre-dose, 1, 2, 4, 6, 8, 12 hours on Day 1, pre-dose on Days 3, 5, 7, 9 and pre-dose, 1, 2, 4, 6, 8, 12 , 24, 36 and 48 hours post-dose on Day 10
Cmax
时间窗: Pre-dose, 1, 2, 4, 6, 8, 12 hours on Day 1, pre-dose on Days 3, 5, 7, 9 and pre-dose, 1, 2, 4, 6, 8, 12 , 24, 36 and 48 hours post-dose on Day 10
Number of subjects with abnormal physical examination findings
时间窗: Up to Day 22
Number of subjects with abnormal blood pressure
时间窗: Up to Day 22
Number of subjects with abnormal heart rate
时间窗: Up to Day 22
Number of subjects with abnormal 12-lead ECG assessment
时间窗: Up to Day 22
次要结局
- Time to max concentration and terminal half-life(Pre-dose, 1, 2, 4, 6, 8, 12 hours on Day 1, pre-dose on Days 3, 5, 7, 9 and pre-dose, 1, 2, 4, 6, 8, 12 , 24, 36 and 48 hours post-dose on Day 10)
- SCORAD(Up to Day 10)
- BSA determination(Up to Day 10)
- clinical photography(Up to Day 10)
- measurement of barrier function using trans-epidermal water loss (TEWL)(Up to Day 10)
- skin biopsy (biomarkers CD4+, CD8+, eosinophils, total IgE)(Up to Day 10)