AME Study in 14C-Foliglurax in healthy male subjects
Research type
Research Study
Full title
Interventional, open-label, single-dose study investigating the absorption, metabolism and excretion (AME) of foliglurax (Lu AF99757) following oral dosing of 14C-foliglurax to healthy men
IRAS ID
253608
Contact name
Jim Bush
Contact email
Sponsor organisation
H. Lundbeck A/S
Eudract number
2018-003720-37
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
REC Reference, 19/NE/0026
Duration of Study in the UK
0 years, 2 months, 0 days
Research summary
Foliglurax is a potent and selective metabotropic glutamate 4 receptor positive, allosteric modulator, currently under development by H. Lundbeck A/S for the treatment of symptoms in patients with Parkinson’s disease as an additional therapy to levodopa.
This is an interventional, open-label, single-dose study investigating the absorption, metabolism and excretion (AME) of foliglurax.
In the study, 6 healthy men will be dosed with a single oral dose of 80 mg [14C]-foliglurax (with a radioactivity dose of approximately 93 μCi = 3.44 MBq). Subjects will be admitted to the clinic on the afternoon of Day -2 (2 days before dosing on Day 1) and will stay in the clinic until at least Day 11. From 24 hours prior to dosing, all urine and faeces will be collected in pre-specified intervals for assessment of excreted radioactivity. Subjects will be discharged on Day 11 if ≥90% of the total amount of radioactivity that was dosed has been recovered in the urine and faeces. If less than 90% of the radioactive dose has been recovered on Day 11, subjects will stay confined until the cumulative recovery of radioactivity in both urine and faeces is ≥ 90% of the radioactive dose or, less than 1% of the radioactive dose daily for 3 consecutive days. However, subjects will only be confined for a maximum of 17 Days (Day -2 until Day 15). If the excretion criteria are still not fulfilled on Day 15 the subjects will perform up to 2 additional 24-hour home collections of urine and faeces on Days 18 and 21. If the above criteria are not met on Day 21, subjects will not perform additional home collections but will be discharged from the study.
REC name
North East - York Research Ethics Committee
REC reference
19/NE/0026
Date of REC Opinion
9 May 2019
REC opinion
Favourable Opinion