Interventional, open-label, single-dose trial investigating AME of 14C-Lu AF28996 in healthy men
Research type
Research Study
Full title
Interventional, open-label, single-dose trial investigating the absorption, metabolism, and excretion (AME) of Lu AF28996 following a single oral dosing of 14C-Lu AF28996 to healthy men
IRAS ID
1009208
Contact name
Nikolaj Bak
Contact email
Sponsor organisation
H. Lundbeck A/S (Lundbeck)
Research summary
The aim of this trial is to test the properties of the study drug (LuAF28996) in regard to how much is absorbed, broken down and distributed throughout the body, and how quickly it is removed and by which means. Safety, tolerability and side-effects of the drug will also be assessed.
Eight healthy men will be dosed with a single oral dose of 2 mg of the study drug, which has been radio-labelled to assist with tracking its removal from the body. Participants will be fasted for 8 hours prior to dosing. Participants will be confined to the clinic from Day -1 until at least Day 7. During this time, their urine and faeces will be collected to measure how much of the radioactive dose has been recovered from their system. Their blood will also be sampled throughout their stay to measure drug and metabolite blood concentrations.
By Day 7, they must meet both of the following criteria to be discharged:
• 90% of the radioactive dose is recovered
• Less than 1% of the radioactive dose is recovered daily for two consecutive days
If these criteria are not met, participants may stay in the clinic up to Day 14. If still not met, they will be discharged, and return to the clinic for additional overnight sampling extension visits on Days 18 to 19, and if still not met, will return again on Days 22 to 23.REC name
North East - York Research Ethics Committee
REC reference
24/NE/0003
Date of REC Opinion
4 Mar 2024
REC opinion
Further Information Favourable Opinion