BIOAVAILABILITY STUDY OF RO5186582 UNDER FED AND FASTED CONDITIONS

• Research type

  Research Study

• Full title

  A RANDOMIZED, OPEN LABEL, FOUR-PERIOD, FOUR TREATMENT CROSSOVER STUDY TO INVESTIGATE THE COMPARATIVE BIOAVAILABILITY OF FILM COATED TABLET AND GRANULE FORMULATIONS OF RO5186582 UNDER FED AND FASTED CONDITIONS IN HEALTHY VOLUNTEERS

• IRAS ID

  157566

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2014-001762-97

• Research summary

  GABA is a signalling chemical in the brain which acts on specific GABA receptors. These receptors are associated with cognition (mental processing and understanding) and memory. The effect of GABA at these receptors is inhibitory which means it reduces cognitive and memory function. The Study Drug reduces the effect of GABA on its receptor and therefore could potentially improve cognitive function and memory.
  
  Down syndrome is the most common chromosomal anomaly with an incidence of 1 in 650 to 1 in 1000 live births per year worldwide. The primary concern here is intellectual disability which impairs the quality of life in these individuals; yet there is no therapeutic agent available to treat this condition. The lifespan of individuals with Down syndrome has increased significantly and more individuals with Down syndrome are active members of the community. Maximising functional potential through development of drug therapies for cognitive deficits is an important goal.

  In the Ts65Dn mouse model of Down syndrome the Study Drug exhibited cognition-enhancing properties. The Study Drug has been tested in five clinical trials so far, no serious safety concern has been reported in any of these trials.

  A new film-coated immediate release tablet formulation of the Study Drug has been developed, along with a fine granule formulation intended for use in paediatric populations and adults who have difficulty in swallowing.

  The main aim of this study is to compare the pharmacokinetic performance of the film-coated tablet and granule formulations with the intention of establishing bioequivalence (similarity in blood levels) linkage between these two formulations when taken in a fasted and fed state.

• REC name

  North East - York Research Ethics Committee

• REC reference

  14/NE/0138

• Date of REC Opinion

  23 Jun 2014

• REC opinion

  Favourable Opinion