NCT05238948已完成1 期
A Phase 1, Open-label, 1-sequence Crossover Drug-drug-interaction Study to Assess the Effect of Single and Multiple Doses of CKD-506 on the Single-Dose Pharmacokinetics of Midazolam, A CYP3A4 Substrate, in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Area Under Curve (AUC) of oral midazolam
研究概览
简要总结
This will be a Phase 1, open-label, 1-sequence crossover drug-drug-interaction study in 16 healthy male subjects to assess the effect of single and multiple doses of CKD-506 on the single-dose PK of oral midazolam. Midazolam will be used as a cytochrome P450 (CYP)3A4 substrate in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects
- •Ability and willingness to abstain from methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks)
- •Ability and willingness to abstain from foods and beverages containing grapefruit, Seville oranges, pomelos, star fruit, or cranberries
排除标准
- •History of relevant drug and/or food allergies.
- •Using tobacco products
- •Positive drug and alcohol screen
研究组 & 干预措施
Midazolam with/without CKD-506
Experimental
Single arm and 1-sequence crossover
干预措施: Midazolam (Drug)
Midazolam with/without CKD-506
Experimental
Single arm and 1-sequence crossover
干预措施: CKD-506 (Drug)
结局指标
主要结局
Area Under Curve (AUC) of oral midazolam
时间窗: For 24 hours
With and without coadministration of CKD-506
Maximum Plasma Concentration (Cmax) of oral midazolam
时间窗: For 24 hours
With and without coadministration of CKD-506
次要结局
- Time to Maximum Plasma Concentration (Tmax) of CKD-506 and its metabolites following oral single and multiple doses of CKD-506(For 24 hours)
- Cmax of CKD-506 and its metabolites following oral single and multiple doses of CKD-506(For 24 hours)
- Number of participants with treatment emergent adverse events(Over 4 weeks)
- AUC of CKD-506 and its metabolites following oral single and multiple doses of CKD-506(For 24 hours)
- Number of treatment emergent adverse events(Over 4 weeks)
研究者
研究点 (1)
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