Interventional, Randomized, Double-blind, Sequential Cohort, Placebo-controlled, Multiple-dose Trial Investigating the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of Lu AG06474 in Healthy Young Men and Women, With an Open-label, Cross-over, Single-dose Part Investigating the Relative Bioavailability of a Capsule Formulation
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Parts A and B: Number of Participants with Treatment Emergent Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to investigate the safety of multiple oral doses of Lu AG06474, how well the doses are tolerated, and what the body does to the drug after administering it to healthy young participants. This study also aims to compare how the body absorbs and uses Lu AG06474 when it is given in capsule form versus when it is given as an oral solution.
详细描述
The study has 2 parts: Part A and Part B.
Part A consists of up to 7 sequential cohorts (Cohorts A1 to A7), with 8 participants per cohort randomized to receive multiple doses of either Lu AG06474 or placebo: 6 will receive Lu AG06474 oral solution and 2 will receive placebo.
Part B consists of 1 cohort (Cohort B1), with 12 participants: all participants will receive 2 single doses of Lu AG06474 (one as an oral solution and one in capsule form), taken 3 days apart.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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 Baseline Visit.
- •The participant has a resting supine pulse ≥50 and ≤100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit. For physically/athletically well-trained participants, the lower limit is ≥45 bpm.
- •The participant has a resting supine systolic blood pressure ≥91 and ≤140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure ≥51 and ≤85 mmHg at the Screening Visit and at the Baseline Visit.
排除标准
- •The participant has previously been dosed with Lu AG
- •The participant has participated in a clinical trial <30 days prior to the Screening Visit.
- •The participant has taken any investigational medicinal product ≥30 days or <5 half-lives of that product, whichever is longer, prior to the first dose of IMP.
研究组 & 干预措施
Part A: Multiple Doses of Lu AG06474 or Placebo
Participants will receive multiple oral doses of Lu AG06474 or placebo.
干预措施: Lu AG06474 (Drug)
Part A: Multiple Doses of Lu AG06474 or Placebo
Participants will receive multiple oral doses of Lu AG06474 or placebo.
干预措施: Placebo (Drug)
Part B: Single Doses of Lu AG06474
Participants will receive single oral doses of Lu AG06474.
干预措施: Lu AG06474 (Drug)
结局指标
主要结局
Parts A and B: Number of Participants with Treatment Emergent Adverse Events (AEs)
时间窗: Up to Day 10
Part A: Electrocardiogram (ECG) Parameter (delta QTcF) on Day 5
时间窗: Day 5
Parts A and B: Cmax: Maximum Observed Plasma Concentration of Lu AG06474
时间窗: Predose to Day 6
Part A: AUC0-τ: Area Under the Lu AG06474 Plasma Concentration Curve During Dosing Interval
时间窗: Predose to Day 7
Parts A and B: Tmax: Nominal Time Corresponding to the Occurrence of Cmax
时间窗: Predose to Day 6
Parts A and B: t½: Apparent Elimination Half-life of Lu AG06474
时间窗: Predose to Day 6
Part B: AUC0-infinity: Area Under the Lu AG06474 Plasma Concentration Curve From Zero to Infinity
时间窗: Predose to Day 6
Part A: Accumulation Index
时间窗: Predose to Day 7
Part B: Frel: Relative Bioavailability
时间窗: Predose to Day 6
次要结局
未报告次要终点