Investigation of AFQ056 formulations in fed and fasted conditions.

• Research type

  Research Study

• Full title

  A randomized, open-label, five period, crossover study to evaluate the single dose pharmacokinetics and food effect of two pediatric AFQ056 formulations in healthy adults.

• IRAS ID

  74680

• Contact name

  Salvatore Febbraro

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2011-000365-12

• ISRCTN Number

  1

• Clinicaltrials.gov Identifier

  1

• Research summary

  The purpose of this study is to assess how much of a drug called AFQ056 gets into the bloodstream when given as an oral suspension. The levels of the drug will be assessed under ??fed?? and ??fasted?? conditions and compared to AFQ056 when given as a capsule. AFQ056 has been tested in 18 clinical studies previously which included approximately 570 volunteer and patients. During the previous clinical trials AFQ056 has been safe and well tolerated. This drug is being developed for the treatment of Fragile X Syndrome (FXS) which is a genetic disease. The sponsor, Novartis Pharma AG, will provide funding for this research. This is an open-label (both subjects and researchers will know which treatment is being received), 5 period crossover (each subject will receive all 5 treatments) study in a total of 30 healthy volunteers. There will be 5 Treatment Periods in total, each consisting of 3 overnight stays at Simbec and separated by a minimum of 5 days. The study will be conducted as 2 groups of 15 subjects. Blood samples will be collected for the measurement of AFQ056, as well as safety screens, pregnancy tests and pharmacogentic analysis. Other safety parameters will also be measured at pre-determined time-points during the study, these include blood pressure, pulse, body temperature and 12 lead ECG. Adverse events will be monitored throughout the study.

• REC name

  Wales REC 1

• REC reference

  11/WA/0024

• Date of REC Opinion

  9 Mar 2011

• REC opinion

  Favourable Opinion