Interventional, Open-label, Repeated Single-dose Trial Investigating the Effects of Enzyme Inhibition on the Pharmacokinetic Profile of Lu AF28996 and Its Metabolites in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Maximum Observed Concentration (Cmax) of Lu AF28996
研究概览
简要总结
The purpose of this study is to investigate repeated doses of Lu AF28996 in healthy participants and co-administered with two other compounds, and in a separate cohort following co-administration with antibiotics, to see how well the doses are tolerated and what the body does to the drug after administering it.
详细描述
The study has 2 parts: Part A and Part B.
Part A will consist of 2 cohorts (Cohorts A1 to A2), with 8 participants per cohort and will receive single doses of Lu AF28996 alone and in combination with enzyme inhibitors.
Part B will consist of one cohort (Cohort B1), with 8 participants who will all receive single doses of Lu AF28996 alone and in combination with amoxicillin/clavulanic acid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms per meter squared (kg/m^2) at the Screening Visit and at the Safety Baseline Visit.
- •The participant has a resting supine pulse ≥50 and ≤100 beats per minute (bpm) at the Screening Visit and at the Safety Baseline Visit.
- •The participant has a resting supine systolic blood pressure ≥90 and ≤140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure ≥50 and ≤90 mmHg at the Screening Visit and at the Safety Baseline Visit.
- •The participant has a normal circadian rhythm, defined as a person who usually wakes between 6:00 and 9:00 a.m. and goes to sleep between 9:00 p.m. and midnight.
排除标准
- •The participant is a member of the site staff or of their immediate families or is a subordinate (or immediate family member of a subordinate) to any of the site staff.
- •Part B only, the participant is a woman of childbearing potential AND is using oral hormonal contraceptives.
- •The participant has previously been enrolled in this trial.
- •The participant has previously been dosed with Lu AF
- •Note: Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Part B: Lu AF28996 with Antibiotics
Participants will receive single doses of Lu AF28996 and amoxicillin/clavulanic acid.
干预措施: Lu AF28996 (Drug)
Part B: Lu AF28996 with Antibiotics
Participants will receive single doses of Lu AF28996 and amoxicillin/clavulanic acid.
干预措施: Amoxicillin/clavulanic acid (Drug)
Part A: Lu AF28996 with Enzyme Inhibitors
Participants will receive repeated single doses of Lu AF28996 and enzyme inhibitors.
干预措施: Lu AF28996 (Drug)
Part A: Lu AF28996 with Enzyme Inhibitors
Participants will receive repeated single doses of Lu AF28996 and enzyme inhibitors.
干预措施: Acetylsalicylic Acid (Drug)
Part A: Lu AF28996 with Enzyme Inhibitors
Participants will receive repeated single doses of Lu AF28996 and enzyme inhibitors.
干预措施: Mefenamic Acid (Drug)
结局指标
主要结局
Maximum Observed Concentration (Cmax) of Lu AF28996
时间窗: Predose to Day 13
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Lu AF28996
时间窗: Predose to Day 13
次要结局
- Nominal Time Corresponding to the Occurrence of Cmax(Predose to Day 13)