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| ID | Type | Description | Link |
|---|---|---|---|
| J2O-MC-EKBD | 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 (LY3473329), 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 when taken orally, compared to when injected directly into the vein, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts. The study will last up to approximately 9 and 7 weeks for part 1 and 2, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-LY3473329 (Part 1) | Experimental | Single dose of [¹⁴C]-LY3473329 administered orally |
|
| LY3473329 + [14C]-LY3473329 (Part 2) | Experimental | Single dose of LY3473329 administered orally followed by a single dose of [¹⁴C]-LY3473329 administered intravenously (IV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-LY3473329 | Drug | Administered orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Day 1 up to Day 29 post dose |
| Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Day 1 up to Day 29 post dose |
| Part 2: Pharmacokinetics (PK): Absolute bioavailability (F) of LY3473329 | Part 2: PK: F of LY3473329 | Day 1 up to Day 9 post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3473329 | Part 1: PK: AUC(0-tlast) of LY3473329 | Day 1 up to Day 29 post dose |
| Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of Total Radioactivity |
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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 |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit | Holbeck | Leeds | LS11 9EH | United Kingdom |
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| [14C]-LY3473329 |
| Drug |
Administered IV |
|
| LY3473329 | Drug | Administered orally |
|
Part 1: PK: AUC(0-tlast) of Total Radioactivity |
| Day 1 up to Day 29 post dose |
| Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of LY3473329 | Part 1: PK: AUC(0-∞) of LY3473329 | Day 1 up to Day 29 post dose |
| Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of Total Radioactivity | Part 1: PK: AUC(0-∞) of Total Radioactivity | Day 1 up to Day 29 post dose |
| Part 1: PK: Maximum Concentration (Cmax) of LY3473329 | Part 1: PK: Cmax of LY3473329 | Day 1 up to Day 29 post dose |
| Part 1: PK: Maximum Concentration (Cmax) of Total Radioactivity | Part 1: PK: Cmax of Total Radioactivity | Day 1 up to Day 29 post dose |
| Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) | Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) | Day 1 up to Day 29 post dose |
| Part 1: Total Number of Metabolites of LY3473329 | Part 1: Total Number of Metabolites of LY3473329 | Day 1 up to Day 29 post dose |
| Part 2: PK: AUC (0-∞) of LY3473329 | Part 2: PK: AUC (0-∞) of LY3473329 | Day 1 up to Day 9 post dose |
| Part 2: PK: AUC (0-∞) of [14C]-LY3473329 | Part 2: PK: AUC (0-∞) of [14C]-LY3473329 | Day 1 up to Day 9 post dose |
| Part 2: PK: AUC (0-∞) of Total Radioactivity | Part 2: PK: AUC (0-∞) of Total Radioactivity | Day 1 up to Day 9 post dose |
| Part 2: PK: Cmax of LY3473329 | Part 2: PK: Cmax of LY3473329 | Day 1 up to Day 9 post dose |
| Part 2: PK: Cmax of [14C]-LY3473329 | Part 2: PK: Cmax of [14C]-LY3473329 | Day 1 up to Day 9 post dose |
| Part 2: PK: Cmax of Total Radioactivity | Part 2: PK: Cmax of Total Radioactivity | Day 1 up to Day 9 post dose |
| Part 2: Total Radioactivity Recovered in Urine and Feces | Part 2: Total Radioactivity Recovered in Urine and Feces | Day 1 up to Day 9 post dose |