临床试验/NCT04419636

NCT04419636已完成1 期

Interventional, Open-label, Position Emission Tomography (PET) Study Investigating MAGL Occupancy After Single and Multiple Oral Doses of Lu AG06466 in Healthy Male Subjects

H. Lundbeck A/S1 个研究点分布在 1 个国家目标入组 16 人开始时间: 2020年5月29日最近更新: 2021年2月24日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: H. Lundbeck A/S
入组人数: 16
试验地点: 1
主要终点: Central monoacylglycerol lipase (MAGL) occupancy

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A study to learn how Lu AG06466 and one of its break down products binds in the brain after single and repeated dosing

详细描述

The study will be conducted in two Parts. Part A: cross over, fed/fasted determined by randomized sequence Part B: sequential group

PET scans will be used to quantify MAGL occupancy

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•body weight ≥60 kg.
•body mass index ≥18.5 and ≤27 kg/m
•waist circumference ≤94 cm.
•The subject has a normal sMRI performed during the screening period.
•The subject is suitable for radial artery blood sampling and cannulation as demonstrated by the Allen test.
•Subject must be healthy as assessed using detailed medical history, laboratory tests, and physical examination.
•The subject must make use of contraception.

排除标准

•The subject is left handed.
•Other in- and exclusion criteria may apply

研究组 & 干预措施

Part A Single doses

Experimental

Lu AG06466 in fast and fed state

干预措施: Lu AG06466 (Drug)

Part B Repeated doses

Experimental

Lu AG06466 after light meal

干预措施: Lu AG06466 (Drug)

结局指标

主要结局

Central monoacylglycerol lipase (MAGL) occupancy

时间窗: From dosing to 8 hours post-dose

次要结局

C(PET)(From zero to Day 10)
Cmax(From zero to 24 hours post-dose)
AUC (0-24)(From zero to 24 hours post-dose)

研究者

发起方

H. Lundbeck A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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