AME of Idalopirdine
Research type
Research Study
Full title
Interventional, open-label, two single dose, fixed-sequence study investigating the absorption, metabolism and excretion (AME) of idalopirdine following a single oral dose of Lu AF67708 ([ethyl-1-14C]-idalopirdine) and Lu AF67709 ([benzyl-7-14C]-idalopirdine) to healthy men
IRAS ID
172109
Contact name
Jim Bush
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2013-004001-28
Duration of Study in the UK
0 years, 2 months, 4 days
Research summary
Idalopirdine (Lu AE58054) is a medication under development as a potential treatment for Alzheimer’s Disease (AD).
As of 1-December-2014, a total of 505 healthy volunteers or patients have been treated with Idalopirdine in clinical studies.
This is an open label (i.e. volunteers and study staff will know the medication and dose being used for each volunteer), study conducted in healthy male volunteers. Idalopirdine will be radiolabelled with 14C. Radiolabelled means that the drug has an invisible radioactive tag, allowing us to monitor the drug more closely. Six volunteers will participate in the study as a single group.
Volunteers will be dosed with two single oral doses of 14C-labelled idalopirdine, each with the label in a different position. The dose administration will be separated by a period of =3 weeks. Each dose will be 120 mg of idalopirdine containing 2.40 MBq of carbon-14.
Volunteers will be confined to the clinic for a minimum of 9 days (24 hours pre-dose to 168 hours post-dose) following each dose. From 24 hours prior to dosing, urine and faeces will be quantitatively collected in pre-specified intervals for assessment of excreted radioactivity.
Volunteers will be discharged on Day 8 if more than 90% of the radioactivity has been excreted in urine and faeces. If less than 90% of the radioactive dose has been recovered, volunteers will stay confined until excretion of radioactivity in both urine and faeces is either cumulatively more than 90% or less than 1% of the radioactive dose daily for 3 consecutive days before Day 16. However, volunteers can only be confined for a maximum of 17 Days (from 24 hours pre-dose to 360 hours post-dose).
From dosing to 168 hours post dose, blood samples will be taken for assessing radioactivity in plasma and whole blood, as well as the concentration of idalopirdine.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0074
Date of REC Opinion
7 Apr 2015
REC opinion
Further Information Favourable Opinion