Open Label Study in Healthy Volunteers to Investigate the Effect of Ketoconazole 400mg on Pharmacokinetics of SB-773812 20mg
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Blood sampling over period of 336 hours post dosing with SB-773812
研究概览
简要总结
The purposes of this study are to determine if there is a difference in how SB-773812 is distributed through the bloodstream before and after multiple doses of ketoconazole have been given and to determine if there is a difference in how safe and well tolerated SB-773812 is when given on its own and given with ketoconazole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Subjects receiving ketoconazole for 8 days
In Session 1, subjects will receive a single oral dose of SB-773812 20 milligrams (mg), followed by 21 days-washout. In Session 2, subjects will receive once daily oral dose of ketoconazole 400 mg repeated for 8 days. On day 5, single oral dose of SB-773812 20 mg will be dosed concomitantly with ketoconazole.
干预措施: SB773812 (Drug)
Subjects receiving ketoconazole for 8 days
In Session 1, subjects will receive a single oral dose of SB-773812 20 milligrams (mg), followed by 21 days-washout. In Session 2, subjects will receive once daily oral dose of ketoconazole 400 mg repeated for 8 days. On day 5, single oral dose of SB-773812 20 mg will be dosed concomitantly with ketoconazole.
干预措施: Ketoconazole (Drug)
Subjects receiving ketoconazole for 14 days
In Session 1, subjects will receive a single oral dose of SB-773812 (20mg), followed by 21 days-washout. In Session 2, subjects will receive once daily oral dose of ketoconazole 400 mg repeated for 12 days. On day 5, single oral dose of SB-773812 20 mg will be dosed concomitantly with ketoconazole.
干预措施: SB773812 (Drug)
Subjects receiving ketoconazole for 14 days
In Session 1, subjects will receive a single oral dose of SB-773812 (20mg), followed by 21 days-washout. In Session 2, subjects will receive once daily oral dose of ketoconazole 400 mg repeated for 12 days. On day 5, single oral dose of SB-773812 20 mg will be dosed concomitantly with ketoconazole.
干预措施: Ketoconazole (Drug)
结局指标
主要结局
Blood sampling over period of 336 hours post dosing with SB-773812
时间窗: over period of 336 hours post dosing
次要结局
- Safety: ECG, vital signs, adverse events, clinical labs over 48 hours post SB-773812 dosing.(over 48 hours post SB-773812 dosing.)