Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-26 @ 6:47 PM
Study NCT ID:
NCT04991766
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2021-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of [¹⁴C]-LY3484356 in Healthy Female Participants
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
An Open-label, Two-part Study of the Disposition and Absolute Bioavailability of [¹⁴C]-LY3484356 in Healthy Females of Non-Childbearing Potential
Status:
COMPLETED
Status Verified Date:
2025-11-15
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study has two parts. It will involve a single dose of 14C radiolabeled LY3484356. This means that a radioactive substance C14 will be incorporated into the study drug, to investigate the study drug and its breakdown products, to find out how much of these pass from blood into urine, feces and expired air. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| J2J-MC-JZLE | OTHER | Eli Lilly and Company | View |