*Open-label, Two-part Study of the Disposition and Bioavailability of [14C]-LY3549492 in Participants
Research type
Research Study
Full title
An Open-label, Two-part Study of the Disposition and Absolute Bioavailability of [14C]-LY3549492 in Healthy Participants.
IRAS ID
1008349
Contact name
Niamh O Shea
Contact email
Sponsor organisation
Eli Lilly and Company
Clinicaltrials.gov Identifier
Research summary
This study is An Open-label, Two-part Study of the Disposition and Absolute Bioavailability of [14C] LY3549492 in Healthy Males. LY3549492 is an non-peptide agonist (NPA) of the glucagon-like peptide-1 receptor (GLP-1 R) currently being developed as a potential treatment for Type 2 Diabetes.\nDiabetes.\n\nThe study consists of 2 proposed parts. \n\nPart A of the study aims to determine how the study drug is handled by the body, how it is removed from the body (excreted) and to determine breakdown products of the study drug (metabolites).\n\nParticipants will be admitted to the CRU on Day -1. On the morning of Day 1, participants will receive a single oral dose of 25 mg of [14C]-LY3549492 administered as a solution.\nParticipants will be discharged from the CRU as early as Day 5 and up to Day 24, provided recovery of radioactivity has reached both of the following threshold values:\n-\t≥90% of the administered radioactive dose is recovered, and\n-\t≤1% of the radioactive dose per day is recovered in excreta (urine and faeces combined) for 2 consecutive days on which a faecal sample is collected.\nSample collection and CRU confinement will continue until discharge criteria are met or the maximum stay (Day 24) is reached.\n\nPart B of the study aims to compare the amount of study drug available to the body from an oral dose in comparison to an intravenous dose.\nParticipants will be admitted to the CRU on Day -1. On the morning of Day 1, participants will receive a single oral dose of 25 mg of LY3549492 as 25-mg capsule. Three hours later, a single dose of approximately 45 μg of [14C]-LY3549492 will be administered as a 15-minute (±1 minute) intravenous (into the vein) infusion. Participants will remain resident in the CRU until Day 7.\n\nAll participants will receive a follow-up call 7 ± 2 days after clinic discharge.
REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0614
Date of REC Opinion
2 Nov 2023
REC opinion
Further Information Favourable Opinion