PK Study to Evaluate Effect of Semegacestat on Donepezil & Galantamine

• Research type

  Research Study

• Full title

  A Pharmacokinetic Study to Evaluate the Effect of Semagacestat on Donepezil and Galantamine in Healthy Subjects

• IRAS ID

  59063

• Contact name

  Joseph Chiesa

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2010-020500-30

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Eli Lilly and Company are developing a new drug, Semagacestat (LY450139) for Alzheimer??s disease, a progressive and potentially fatal neurodegenerative disorder. During the course of the disease, 'plaques' and 'tangles' develop in the structure of the brain, leading to the death of brain cells. Semagacestat has an effect on the rate of formation of these plaques, thereby decreasing plaque formation in the brain and slowing down the progression of dementia. In clinical studies completed to date, Semagacestat has been generally well tolerated when administered to healthy subjects as single doses up to 280 mg and as multiple doses up to 140 mg for 28 days.This study will take place in 2 parts with 2 periods in each part. The study will be open label and administered in a fixed sequence in healthy male and female subjects who will participate in the donepezil group (Part A) or galantamine group(Part B) only. Part A(Donepezil):In Period 1, all subjects will receive a single oral dose of 10 mg donepezil on Day 1, followed by an 18 to 20day washout period. In Period 2, all subjects will receive 140 mg Semagacestat four times a day for 14 consecutive days (Days 1 to 14). A single oral dose of 10 mg Donepezil will be administered simultaneously with the 10th dose of Semagacestat on Day 10. Part B(Galantamine ER):In Period 1, all subjects will receive a single oral dose of 16 mg galantamine ER on Day 1, followed by a 5 to 7 day washout period. In Period 2, all subjects will receive 140 mg Semagacestat four times a day for 11 consecutive days (Days 1 to 11). A single oral dose of 16 mg Galantamine ER will be administered simultaneously with the 10th dose of Semagacestat on Day 10.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC05/19

• Date of REC Opinion

  12 Aug 2010

• REC opinion

  Further Information Favourable Opinion