Interventional, Open-label, Randomized, Two-sequence Study Evaluating the Effect of CYP3A4 Inhibition on the Pharmacokinetics, Safety and Tolerability of Lu AG06466 in Healthy Men and Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- AUC(0-inf) Lu AG06466
研究概览
简要总结
A study to learn how a drug (itraconazole) that is known to inhibit a certain enzym in the liver, impacts the body's ability to breakdown Lu AG06466 into breakdown products in healthy men and women. The main breakdown product is Lu AG06988.
详细描述
Two sequence study where Lu AG06466 will be dosed with and without food, Sequence 1 and Sequence 2. Each subject will receive single oral doses of Lu AG06466. Subject will be randomized to one of two sequences.
For inhibition of CYP3A4, each subject will receive a once daily dosage of itraconazole from Day 5 to Day 11.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •The subject has a BMI ≥18.5 and ≤30 kg/m2
- •The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
- •The subject must not be of childbearing potential (if a woman) or should use contraception (both sexes). If women, the subject must not be pregnant or breastfeeding.
排除标准
- •The subject is a poor metabolizer (PM) of CYP2C9 and/or CYP2C
- •Other in- and exclusion criteria may apply
研究组 & 干预措施
Lu AG06466 - Sequence 1
Dosing on Days 1 and 8 will be following an overnight fast, and dosing on Days 3 and 10 will be following a standard high-fat breakfast.
干预措施: Itraconazole (Drug)
Lu AG06466 - Sequence 1
Dosing on Days 1 and 8 will be following an overnight fast, and dosing on Days 3 and 10 will be following a standard high-fat breakfast.
干预措施: Lu AG06466 (Drug)
Lu AG06466 - Sequence 2
Dosing on Days 1 and 8 will be following, a standard high-fat breakfast and dosing on Days 3 and 10 will be following an overnight fast.
干预措施: Lu AG06466 (Drug)
Lu AG06466 - Sequence 2
Dosing on Days 1 and 8 will be following, a standard high-fat breakfast and dosing on Days 3 and 10 will be following an overnight fast.
干预措施: Itraconazole (Drug)
结局指标
主要结局
AUC(0-inf) Lu AG06466
时间窗: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
Area under the Lu AG06466 plasma concentration-time curve from time zero to infinity
Cmax Lu AG06466
时间窗: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
Maximum observed plasma concentration (Cmax) of Lu AG06466
Cmax Lu AG06988
时间窗: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
Maximum observed plasma concentration (Cmax) of Lu AG06988
AUC(0-inf) Lu AG06988
时间窗: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
Area under the Lu AG06988 plasma concentration-time curve from time zero to infinity
次要结局
未报告次要终点