Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J3H-MC-GZNC | Other Identifier | Eli Lilly and Company | |
| U1111-1293-8652 | Other Identifier | UTN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 will be conducted in healthy males and has two parts. In Part A, participants will receive carbon-14 (14C) radiolabeled LY3549492 ([14C] LY3549492) given by mouth. In Part B, participants will receive LY3549492 by mouth. Three hours later, participants will receive [14C] LY3549492 given into a vein.
The radioactive substance C14 will be incorporated into the study drug to investigate the study drug and breakdown products to find out how much of these passes from blood into urine, stool, and breath.
The study will last about 2 months in Part A and about 1½ months in Part B. This includes screening, treatment, and follow-up visits.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbon-14-Labeled [14C]-LY3549492 - Part A | Experimental | Carbon-14-Labeled [14C]-LY3549492 administered as oral solution. |
|
| LY3549492 + [14C]-LY3549492 - Part B | Experimental | LY3549492 administered as oral solution followed 3 hours later by [14C] LY3549492 will be administered as intravenous (IV) infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-LY3549492 | Drug | Administered as oral solution. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose in Part A | Urinary Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose | Predose up to Day 24 postdose in Part A |
| Fecal Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose in Part A | Fecal Excretion of Total Radioactivity Over Time Expressed as a Percentage of the Total | Predose up to Day 24 postdose in Part A |
| Pharmacokinetic (PK): Area Under the Curve (AUC) for Oral Determination of Absolute Bioavailability (F) of LY3549492 in Part B | PK: AUC for oral determination of absolute bioavailability (F) of LY3549492 | Predose up to Day 7 postdose in Part B |
| PK: AUC for Intravenous (IV) Determination of Absolute Bioavailability (F) of LY3549492 in Part B | PK: AUC for IV determination of absolute bioavailability (F) of LY3549492 | Predose up to Day 7 postdose in Part B |
| Measure | Description | Time Frame |
|---|---|---|
| PK: Area Under the Concentration (AUC) for Radioactivity in Plasma and Whole Blood in Part A | PK: AUC for radioactivity | Predose up to Day 24 postdose in Part A |
| PK: Maximum Concentration (Cmax) for Radioactivity in Plasma and Whole Blood in Part A |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 : Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit | Holbeck | Leeds | LS11 9EH | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| LY3549492 |
| Drug |
Administered orally. |
|
| [14C]-LY3549492 | Drug | Administered as IV infusion. |
|
PK: Cmax for radioactivity
| Predose up to Day 24 postdose in Part A |
| PK: AUC of LY3549492 in Plasma in Part A | PK: AUC of LY3549492 in plasma | Predose up to Day 24 postdose in Part A |
| PK: Cmax of LY3549492 in Plasma in Part A | PK: Cmax of LY3549492 in plasma | Predose up to Day 24 postdose in Part A |
| Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) in Part A | Total radioactivity recovered in urine, feces, and expired air (if applicable) in Part A | Predose up to Day 24 postdose in Part A |
| Total Number of Metabolites and Identification of Metabolites of LY3549492 in Part A | Total number of metabolites and identification of metabolites of LY3549492 | Predose up to Day 24 postdose in Part A |
| PK: AUC of LY3549492, [14C]-LY3549492, and Total Radioactivity in Plasma in Part B | AUC of LY3549492, [14C]-LY3549492, and total radioactivity in plasma in Part B | Predose up to Day 7 postdose in Part B |
| PK: Cmax of LY3549492, [14C]-LY3549492, and Total Radioactivity in Plasma in Part B | Cmax of LY3549492, [14C]-LY3549492, and total radioactivity in plasma in Part B | Predose up to Day 7 postdose in Part B |
| Total Radioactivity Recovered in Urine and Feces in Part B | Total radioactivity recovered in urine and feces in Part B | Predose up to Day 7 postdose in Part B |