Safety, Tolerability and PK of Single Ascending Doses of Lu AF11167 v1
Research type
Research Study
Full title
A Randomised, double-blind, sequential-group, placebo controlled, single ascending oral dose study investigating the safety, tolerability, pharmacokinetic, pharmacodynamic and metabolite profile of Lu AF11167 in healthy young men, and an open label crossover to study intra-subject variability and effects of food
IRAS ID
72823
Contact name
Joseph Chiesa
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2010-023607-98
Research summary
Lu AF11167 (“Study drug”) is an investigational drug which is being developed by H. Lundbeck A/S.
Part A of this Study has been designed to look at how safe and well tolerated the Study drug is, how much of the drug gets into the blood stream and what affect the drug has on the body. Part B of the study will compare how much of the drug gets into the blood stream with and without food, how long it takes the body to remove it.
Up to 81 volunteers are planned to take part in this single site research study. The study will be conducted in two parts. Part A will be conducted as up to 8 cohorts (groups) and Part B will be one cohort. Each cohort will contain 9 volunteers. In one cohort from Part A of this study volunteers will take a small amount of radioactive substance built into the study drug ([14C]Lu AF11167). This will help us to investigate the study drug and its breakdown products and to find out if any products pass from the blood into urine and faeces. Also, the effect of the study drug on the electrical activity of the brain will be investigated in up to 3 cohorts from Part A.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
11/IE/0028
Date of REC Opinion
21 Mar 2011
REC opinion
Further Information Favourable Opinion