Semagacestat-Digoxin DDI study

• Research type

  Research Study

• Full title

  Effect of Semagacestat on Steady State Digoxin Pharmacokinetics in Healthy Subjects

• IRAS ID

  59230

• Contact name

  Ashley Brooks

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2010-019443-19

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Alzheimer??s disease is a progressive and potentially fatal disorder of the brain and is the most common cause of dementia, affecting around 417,000 people in the UK itself. Alzheimer's disease, first described by the German neurologist Alois Alzheimer, is a physical disease affecting the brain. During the course of the disease, plaques develop in the structure of the brain, leading to the death of brain cells. Semagacestat (LY450139) is a drug being developed with the aim to slow the rate of disease progression in patients with Alzheimer??s disease (AD) by reducing the formation of such plaques. This is a single-centre, open-label, fixed-sequence study involving at least 24 healthy male and female subjects. All subjects will orally receive once daily doses of 0.25 mg digoxin from Day 1 to Day 22 of the study. On Days 13 to 22, all subjects will receive once daily oral doses of 140 mg semagacestat, administered concurrently with digoxin. Morning doses of semagacestat and digoxin will be administered together after at least an 8 hour fast on Days 12, 13, and 22, and continue to fast for 2 hours after dosing. A follow-up visit will occur 10 to 15 days after the last dose for each subject.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC05/20

• Date of REC Opinion

  12 Aug 2010

• REC opinion

  Further Information Favourable Opinion