Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627088
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
A Study of LY4100511 DC-853 Mass Balance and Absolute Bioavailability of LY4100511 in Healthy Male Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Open-label Two-part Study of the Absorption Metabolism Excretion and Bioavailability of LY4100511 DC-853 Following Administration of 14C-LY4100511 in Healthy Male Participants
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study has two parts Part A and Part B The purpose of Part A is to determine the absorption metabolism and excretion AME of 14C-LY4100511 and to characterize and determine the metabolites present in plasma urine and feces in healthy male participants after a single oral dose of LY4100511 The purpose of Part B is to determine the absolute bioavailability of LY4100511 in humans to further analyze the rate and routes of excretion including the mass balance and to further investigate the pharmacokinetics PK of 14C-LY4100511 LY4100511 and TRA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None