An Open-Label Study to Evaluate the Effect of a Single Dose of Briakinumab on the Pharmacokinetics of Single Doses of Caffeine, Tolbutamide, Omeprazole, Metroprolol, and Midazolam in Subjects With Moderate to Severe Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- Abbott
- 入组人数
- 12
- 主要终点
- Assessment of the drug-drug interaction potential of briakinumab (ABT-874) with cytochrome CYP 1A2. CYP2C9, CYP2C19, CYP2D6 and CYP3A4 in moderate to severe plaque psoriasis subjects
研究概览
简要总结
Phase 1, drug-drug interaction study to evaluate the effects of Briakinumab on hte pharmacokinetics of single doses of CYP substrate in subjects with moderate to severe psoriasis.
详细描述
The study does involve 3 days confinement at the beginning of the trial and 4 days at the end of the trial. The trial duration is 17 days with 6 visits not including the confinement periods. The trial is being conducted in moderate to severe plaque psoriasis subjects. Serial blood samples will be taken after each doses of the CYP substrates are administered and blood samples will be collected for briakinumab PK and briakinumab ADA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（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 of briakinumab
single dose briakinumab cocktail of CYP substrates
干预措施: briakinumab (Drug)
结局指标
主要结局
Assessment of the drug-drug interaction potential of briakinumab (ABT-874) with cytochrome CYP 1A2. CYP2C9, CYP2C19, CYP2D6 and CYP3A4 in moderate to severe plaque psoriasis subjects
时间窗: 17 days
CYP Substrate cocktail administed at Day -1 and day 14 and Briakinumab at Day 1
次要结局
- No secondary outcomes are reported for this study(No secondary outcomes are reported for this study)