Interventional, Open-label, One-sequence Crossover Study Evaluating the Effect of Multiple Doses of Itraconazole (Inhibitor of CYP3A4/5) on the Pharmacokinetics, Safety and Tolerability of Lu AF35700 in Healthy Young Men and Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- AUC(0-inf)
研究概览
简要总结
This study will investigate the effect of multiple doses of the strong P450 enzyme inhibitor itraconazole on the pharmacokinetics of Lu AF35700 in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men, aged ≥18 and ≤55 years. body weight ≥50 kg
- •women, aged ≥18 and ≤45 years, body weight ≥50 kg
- •Good general health as assessed using detailed medical history, laboratory tests, and physical examination
- •Known CYP2D6 and CYP2C19 genotype
排除标准
- •Pregnant or lactating
- •Subject has previously been dosed with Lu AF35700
- •Other protocol defined inclusion and exclusion criteria may apply
研究组 & 干预措施
Lu AF35700
Day 1: Single dose of Lu AF35700. Extensive metabolisers (EMs): 10mg. Poor metabolisers (PMs): 5 mg
干预措施: Lu AF35700 (Drug)
Lu AF35700 AND itraconazole
Days 29 to 31: once-daily dosage of 200 mg itraconazole. Day 32: Single dose of Lu AF35700 (EMs: 10 mg, PMs: 5 mg) and 300 mg itraconazole Days 33 to 42: once-daily dosage of 200 mg itraconazole
干预措施: Lu AF35700 (Drug)
Lu AF35700 AND itraconazole
Days 29 to 31: once-daily dosage of 200 mg itraconazole. Day 32: Single dose of Lu AF35700 (EMs: 10 mg, PMs: 5 mg) and 300 mg itraconazole Days 33 to 42: once-daily dosage of 200 mg itraconazole
干预措施: Itraconazole (200 mg) (Drug)
Lu AF35700 AND itraconazole
Days 29 to 31: once-daily dosage of 200 mg itraconazole. Day 32: Single dose of Lu AF35700 (EMs: 10 mg, PMs: 5 mg) and 300 mg itraconazole Days 33 to 42: once-daily dosage of 200 mg itraconazole
干预措施: Itraconazole (300 mg) (Drug)
结局指标
主要结局
AUC(0-inf)
时间窗: Day 1: Predose to day 29 postdose, Day 32: Predose to day 74 postdose
Area under the Lu AF35700 plasma concentration-time curve (with and without itraconazole) for CYP2D6 EMs
Cmax
时间窗: 0-24 hours postdose (Day 1 and day 32)
Maximum observed plasma concentration of Lu AF35700 (with and without itraconazole) for CYP2D6 EMs
次要结局
未报告次要终点