Phase I study investigating AME of Lu AG06466 in healthy men
Research type
Research Study
Full title
Interventional, open-label, single-dose study investigating the absorption, metabolism and excretion (AME) of Lu AG06466 following oral dosing of 14C-Lu AG06466 to healthy men
IRAS ID
305805
Contact name
Firas Almazedi
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2021-002048-54
Duration of Study in the UK
0 years, 1 months, 13 days
Research summary
Lu AG06466 is a drug being developed for the treatment of malignant conditions and is an orally available, brain-penetrant, selective and irreversible inhibitor of MAGL for the treatment of neurological and psychiatric conditions that can benefit from enhancing the function of the endocannabinoid system (ECS), in particular 2-arachidonoylglycerol signalling.
The study will be an open label single-dose study to investigating the absorption, metabolism and excretion (AME) (how quickly the drug gets into the blood stream and how quickly it is removed from the body) following oral dosing of 14C-Lu AG06466 in 6 healthy male participants who will be given a single oral dose of 20 mg [14C]-Lu AG06466 (approximately 39 μCi = 1.44 MBq) in the fed state following a high-fat meal and will be confined for a minimum of 8 days (from 24 hours pre-dose on Day -1 until 144 hours post-dose on Day 7).
Starting from 24 hours pre-dose, urine and faeces will be collected in pre-specified intervals for assessment of excreted total radiolabelled drug-related material. Participants will be discharged on Day 7 if ≥90% of the radioactive dose has been excreted in urine and faeces. If <90% of the radioactive dose has been recovered, participants will stay in the clinic until 312 hours post-dose on Day 14 or until excretion of total radiolabelled drug-related material in both urine and faeces is:
-Cumulatively ≥90% of the radioactive dose, or -<1% of the radioactive dose, daily, for 3 consecutive 24-hour sampling intervals, where both urine and faeces collections have occurred, up until and including Day 14 (up to 312 hours post-dose).If at 312 hours on Day 14 the participant has not fulfilled the recovery criteria, they will be discharged and return to the clinic for up to two additional overnight sampling extension visits on Days 22 to 23.
REC name
North East - York Research Ethics Committee
REC reference
21/NE/0176
Date of REC Opinion
12 Nov 2021
REC opinion
Favourable Opinion