Safety, tolerability, PK and PD of LU AF76432 in healthy, young men
Research type
Research Study
Full title
Interventional, randomized, double-blind, sequential-group, placebo-controlled, single-ascending-oral-dose study investigating the safety, tolerability, pharmacokinetic, and pharmacodynamic properties of Lu AF76432 in healthy young men
IRAS ID
242614
Contact name
Pablo Forte Soto
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2017-001322-18
Duration of Study in the UK
0 years, 7 months, 6 days
Research summary
The compound tested in this study, Lu AF76432, is being developed by Lundbeck A/S to treat patients with cognitive and behavioral problems. The means by which the drug is hoped to improve cognitive/behavioral problems is by enhanced signaling (communication) between nerve cells in the brain. This study is the first time that Lu AF76432 will be given to human participants.
The main purpose of this study is to determine the safety and tolerability of the drug, when administered in increasing dose strengths to a population of healthy, young men. The study will also investigate how the drug is absorbed (taken up in the body). A further aim of the study is to assess how the drug affects the brain.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0013
Date of REC Opinion
4 Apr 2018
REC opinion
Further Information Favourable Opinion