Single ascending dose + food effect study of Lu AF30746

• Research type

  Research Study

• Full title

  Interventional, randomised, double-blind, sequential-group, placebo-controlled, single ascending dose study to investigate the safety, tolerability, pharmacokinetic and pharmacodynamic properties and metabolite profile of Lu AF30746 in healthy young men in addition to a randomised, open-label, crossover, single dose study to investigate the intra-subject variability and effect of food in healthy young men

• IRAS ID

  123598

• Sponsor organisation

  H. Lundbeck A/S

• Eudract number

  2012-000060-16

• ISRCTN Number

  N/A

• Research summary

  Lu AF30746 is being developed for treatment of schizophrenia, and is a selective, high affinity inhibitor of the human phosphodiesterase10A (PDE10A) expressed in the central nervous system (mainly in the striatum). Lu AF30746 is expected to be an antipsychotic with an efficacy and safety profile different from currently available antipsychotics due to its novel mode of action of striatal down-stream modulation of synaptic transmission as opposed to receptor blockage. This study is a randomised, double-blinded, sequential-group, placebo-controlled, single ascending dose study in healthy young men to investigate the safety and tolerability of Lu AF30746. In addition the effect of food on the absorption of Lu AF30746 will be investigated.The study is divided into two parts, Part A and Part B. Part A will investigate the safety, tolerability and how the body breaks down Lu AF30746 when given as single doses. Part A will consist of up to 6 cohorts with 9 men in each cohort. Both the subjects and the person administering the dose will be blinded to the actual treatment (Lu AF30746 or placebo). In one cohort, the subjects will be given a low dose of radiolabelled Lu AF30746 to allow identification of the breakdown products of Lu AF30746. Part B will investigate the effect of food on the breakdown of Lu AF30746 in the body will be examined. Part B will consist of one cohort of 9 men. The men will receive four single doses of Lu AF30746 following overnight fasting (on two occasions), a 2-hour fast, and a FDA standard high fat breakfast in a randomised order.

• REC name

  North East - York Research Ethics Committee

• REC reference

  13/NE/0038

• Date of REC Opinion

  19 Feb 2013

• REC opinion

  Further Information Favourable Opinion