NCT02122692已完成1 期
Interventional, Open-label, One-sequence Crossover Study to Evaluate the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Multiple Dose Pharmacokinetics of Lu AE58054 in Healthy 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
- 20
- 试验地点
- 1
- 主要终点
- Area under the Lu AE58054 plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)
研究概览
简要总结
To examine the effect of the strong CYP3A4/5 inhibitor itraconazole (200 mg QD) on the multipledose exposure of Lu AE58054 (30 mg QD) in healthy subjects (CYP2D6 extensive metabolisers).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects are eligible for inclusion into the study if they meet each of the following criteria:
- •Men and women, aged 18 - 45 years.
- •Body weight at least 50 kg and Body Mass index 19 - 28 kg/m
- •Good general health ascertained by a detailed medical history, laboratory tests and physical examination.
- •Non-childbearing potential or use of contraception (both sexes).
- •Women must not be pregnant or lactating.
- •Known CYP2D6 genotype (Extensive metaboliser (n=15) and poor metaboliser (n =5)) .
- •Other Inclusion and Exclusion Criteria may apply.
排除标准
- 未提供
研究组 & 干预措施
Lu AE58054 30 mg + itraconazole 200 mg
Experimental
干预措施: Lu AE58054 30 mg (Drug)
Lu AE58054 30 mg + itraconazole 200 mg
Experimental
干预措施: Lu AE58054 30 mg + itraconazole 200 mg (Drug)
Lu AE58054 30 mg + itraconazole 200 mg
Experimental
干预措施: Itraconazole (Drug)
结局指标
主要结局
Area under the Lu AE58054 plasma concentration-time curve from time zero to 24 hours post-dose (AUC0-24)
时间窗: Day 5 and Day 11
Maximum observed concentration (Cmax) of Lu AE58054
时间窗: Day 5 and Day 11
次要结局
- Plasma pharmacokinetics for Lu AE58054: AUC0-24, Cmax, time at which maximum observed plasma concentration occurred (tmax), apparent oral clearance (CL/F), half life (t½) and apparent volume of distribution Vz/F(Day 5 and Day 11)
- Plasma pharmacokinetics for relevant metabolites: AUC0-24, Cmax, tmax, t½ and metabolic ratio (MR)(Day 5 and Day 11)
- Plasma pharmacokinetic parameters for itraconazole: CTrough(Day 6 to Day 13)
- Adverse events(Up to Day 18, including a safety follow-up)
- Columbia Suicide Severity Rating Scale (C-SSRS) categorization based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions(Up to Day 18, including a safety follow-up)
研究者
研究点 (1)
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