Effect of food on relative bioavailability of amifampridine phosphate

• Research type

  Research Study

• Full title

  A Phase 1, Randomized, Open-Label, Two-Treatment, Two-Period Crossover Study to Evaluate the Effect of Food on Relative Bioavailability of Amifampridine Phosphate (3,4-Diaminopyridine Phosphate) in Healthy Subjects

• IRAS ID

  55239

• Contact name

  Ashley Brooks

• Sponsor organisation

  BioMarin Pharmaceutical Inc

• Eudract number

  2010-020031-40

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Amifampridine has been used for a number of years to treat a variety of diseases affecting the nervous system, including the very rare Lambert-Eaton Myasthenic Syndrome (LEMS). This study is to investigate the effect of food on how this formulation of amifampridine, amifampridine phosphate (3, 4-DAP), is absorbed by the body. A total of forty four subjects will complete the study. Each subject will take part in two treatment periods. At each treatment period subjects will receive a single dose of amifampridine (20 mg) administered as two tablets (10 mg each). Subject will be randomized to receive the treatment after an overnight fast at one treatment period and after a high fat breakfast (consisting of eggs, bacon, toast and hash brown potatoes) at the other. Following each dose serial blood and urine samples will be taken to measure their levels of amifampridine. The levels from each subject at each treatment period will be compared. Over the course of the whole study, blood samples will be taken on a total of thirty four occasions, with a maximum of fifteen samples on any one day. During the study a maximum volume of 230 mls (less than « a pint) of blood will be taken from each subject. At each treatment period subjects will be admitted to the research Unit the evening before dosing and will be discharged approximately twenty four hours after their dose. There will be a seven day washout period between doses at the two treatment periods. Each subject will attend a follow up visit for safety assessments approximately one week after their last dose.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC05/14

• Date of REC Opinion

  23 Jun 2010

• REC opinion

  Further Information Favourable Opinion