NCT01056575已完成1 期
An Open Label Balanced Study in Healthy Subjects to Evaluate the Potential for Cytochrome P 450 3A4 Induction by Oral OC000459 Using Oral Midazolam as a Probe
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Oxagen Ltd
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ratio of exposure of midazolam and 4-hydroxymidazolam (without/with exposure to OC000459) as measured by plasma AUC0-t and Cmax for midazolam and its active metabolite 4-hydroxymidazolam.
研究概览
简要总结
This will be an open label, sequential study of midazolam (dose 5 mg orally) followed by midazolam (5 mg orally) given after dosing with OC000459 100 mg twice daily for 6.5 days. Twenty subjects will be included to ensure at least 16 subjects with analysable PK data. PK sampling for midazolam and 4-hydroxymidazolam plasma concentrations will continue for up to and including 24 hours after dosing with midazolam on both occasions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Judged to be in good health at screening (blood tests, physical examination, medical history)
排除标准
- •Evidence of a clinically significant underlying medical condition that in the opinion of the Investigator would represent a risk to study participation.
研究组 & 干预措施
OC000459
Experimental
干预措施: OC000459 (Drug)
结局指标
主要结局
Ratio of exposure of midazolam and 4-hydroxymidazolam (without/with exposure to OC000459) as measured by plasma AUC0-t and Cmax for midazolam and its active metabolite 4-hydroxymidazolam.
时间窗: 6.5 days
次要结局
- Additional PK parameters of midazolam and its active metabolite 4-hydroxymidazolam(6.5 days)
- Safety and tolerability of OC000459(6.5 days)
研究者
研究点 (1)
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