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| ID | Type | Description | Link |
|---|---|---|---|
| J2P-MC-LXBC | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to evaluate how much of the study drug (LY3556050), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy male participants. The study will also measure how much of the study drug gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study will last up to approximately 58 days including the screening period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-LY3556050 | Experimental | Single dose of [¹⁴C]-LY3556050 administered orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-LY3556050 | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Urinary Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Urinary Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 21 post dose |
| Fecal Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Fecal Excretion of LY3556050 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 21 post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3556050 in Plasma | PK: AUC(0-tlast) of LY3556050 in Plasma | Predose up to Day 21 post dose |
| PK: AUC(0-tlast) of Total Radioactivity in Plasma and Blood |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|---|---|---|---|---|---|---|
| LabCorp CRU, Inc. | Madison | Wisconsin | 53704 | United States |
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PK: AUC(0-tlast) of Total Radioactivity in Plasma and Blood |
| Predose up to Day 21 post dose |
| PK: Area Under the Curve Concentration Versus Time Curve From zero to Infinity (AUC [0-∞]) of LY3556050 in Plasma | PK: AUC (0-∞) of LY3556050 in Plasma | Predose up to Day 21 post dose |
| PK: AUC (0-∞) of Total Radioactivity in Plasma and Blood | PK: AUC (0-∞) of Total Radioactivity in Plasma and Blood | Predose up to Day 21 post dose |
| PK: Maximum Concentration (Cmax) of LY3556050 in Plasma | PK: Cmax of LY3556050 in Plasma | Predose up to Day 21 post dose |
| PK: Cmax of Total Radioactivity in Plasma and Blood | PK: Cmax of Total Radioactivity in Plasma and Blood | Predose up to Day 21 post dose |
| Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) | Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) | Predose up to Day 7 post dose |
| Total Number of Metabolites of LY3556050 | Total Number of Metabolites of LY3556050 | Predose up to Day 7 post dose |