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| ID | Type | Description | Link |
|---|---|---|---|
| I9X-MC-MTAF | 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 (LY3372689), 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [¹⁴C]-LY3372689 | Experimental | Single dose of [¹⁴C]-LY3372689 administered orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [¹⁴C]-LY3372689 | Drug | Administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Urinary Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Urinary Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 17 post dose |
| Fecal Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Fecal Excretion of LY3372689 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Predose up to Day 17 post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC (0-∞)) of Total Radioactivity and [¹⁴C]-LY3372689 | PK: AUC (0-∞) of Total Radioactivity and [¹⁴C]-LY3372689 | Predose up to Day 17 post dose |
| PK: Maximum Concentration (Cmax) of Total Radioactivity and [¹⁴C]-LY3372689 |
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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: Cmax of Total Radioactivity and [¹⁴C]-LY3372689 |
| Predose up to Day 17 post dose |
| PK: Area Under the Concentration-Time Curve From Time Zero to Time (AUC (0-tlast)) of Total Radioactivity and [¹⁴C]-LY3372689 | PK: AUC (0-tlast) of Total Radioactivity and [¹⁴C]-LY3372689 | Predose up to Day 17 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 17 post dose |
| Total Number of Metabolites of LY3372689 | Total Number of Metabolites of LY3372689 | Predose up to 120 hour post dose |