Single & Multiple Dose & Bioavailability Study of Lu AF11167

• Research type

  Research Study

• Full title

  Interventional, randomised, double-blind, parallel-group, placebo controlled, single and multiple dosing regimens study investigating the safety, tolerability, pharmacokinetic, and pharmacodynamic properties of Lu AF11167 in healthy young men and women in addition to a randomised, single dose, open-label, crossover study to investigate the relative bioavailability of an oral solution versus a capsule formulation of Lu AF11167 in healthy young men

• IRAS ID

  92504

• Contact name

  Ashley Brooks

• Sponsor organisation

  H. Lundbeck A/S (Lundbeck)

• Eudract number

  2011-002795-16

• Research summary

  Lu AF11167 is being developed for treatment of schizophrenia, and is a selective, high affinity inhibitor of the human phosphodiesterase 10A (PDE10A) expressed in the central nervous system (mainly in the striatum). Lu AF11167 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 is a randomised, double-blinded, parallel-group single and multiple dosing regimens study in healthy young men and women. In addition the relative bioavailability of an oral solution versus a capsule formulation of Lu AF11167 will be investigated in young men. The study is divided into three parts, Part A, Part B and Part C. Part A Part A will consist of Cohorts 1 to 5. Part A will investigate the safety, tolerability and how the body breaks down Lu AF11167 when given as multiple doses to healthy young men over a period of up to 10 days. Part B Part B will investigate the safety, tolerability and how the body breaks down Lu AF11167 when given as single and multiple doses to healthy young women. Part B will consist of two parts, B1 and B2. In Part B1, the women will be administered 2 single doses of Lu AF11167 separated by a 7 day wash-out period. In part B2, the women will be administered multiple doses of Lu AF11167 over a period of up to 10 days. Part C Part C will consist of a single cohort of male subjects. Each subject will receive 3 single oral doses of study drug. This part of the study will compare how the body handles the oral solution (given fasted) versus the capsule formulation (when given with food) versus the capsule formulation (when given fasted).

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0180

• Date of REC Opinion

  28 Nov 2011

• REC opinion

  Further Information Favourable Opinion