Lu AF35953 - first doses in humans, ver 1

• Research type

  Research Study

• Full title

  Interventional, randomised, double-blind, sequential-group, placebo-controlled, single-ascending-dose study investigating the safety, tolerability, pharmacokinetics, pharmacodynamics and metabolite profile of Lu AF35953 in healthy young men, and open label cross-over to study the intra subject variability and effect of food (HMR code: 12-016)

• IRAS ID

  116291

• Contact name

  Gary Peters

• Sponsor organisation

  H. Lundbeck A/S

• Eudract number

  2012-001269-34

• Research summary

  The study medicine (Lu AF35953) is an experimental treatment for ??cognitive problems?? (such as difficulty with understanding, reasoning, memory), which occur in many brain disorders, including schizophrenia and Alzheimer??s disease. We expect that Lu AF35953 will work by increasing activity of a chemical messenger (acetylcholine) in certain parts of the brain, leading to improved function with fewer side effects than existing treatments. This 2-part study includes up to 93 healthy men, aged 18??45 years, in up to 10 panels. We aim to assess side effects and blood levels of Lu AF35953 taken by mouth (Part A), and find out if food affects blood levels of Lu AF35953 (Part B). Part A: participants will take a single dose of Lu AF35953. It??s never been given to humans before, so We'll start with a low dose, and increase it gradually in subsequent panels. Some participants will take Lu AF35953 that??s ??labelled?? with a small amount of radioactivity, allowing us to detect it in blood, urine, and faeces (poo). Part B: participants will take a single dose of Lu AF35953 in each of 3 sessions: after an overnight fast in 2 sessions; and after a high-fat breakfast in the other session. Participants will take up to 6 (Part A) or 7 (Part B) weeks to finish the study. They??ll make 2 outpatient visits. In Part A, participants will stay on the ward for 4 nights (9 nights for the labelled group); in Part B, they??ll stay for 12 nights in total (4 per session). We'll also test how genes (pieces of DNA) affect how the body handles Lu AF35953. A pharmaceutical company, H.Lundbeck A/S, is funding the study. The study will take place at 1 centre in London. We'll recruit participants by: advertising; word of mouth; volunteer databases; and our websites.

• REC name

  Scotland A REC

• REC reference

  12/SS/0173

• Date of REC Opinion

  30 Oct 2012

• REC opinion

  Favourable Opinion