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| ID | Type | Description | Link |
|---|---|---|---|
| J4X-MC-LWCB | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to investigate the absorption, metabolism, excretion, and bioavailability of LY4065967 in healthy male participants. This is a 2-part study. The study will last about 58 days for participants in Part 1 and about 60 days for participants in Part 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-LY4065967 Part 1 | Experimental | A single dose containing [14C]-LY4065967. |
|
| LY4065967 Part 2 | Experimental | A single dose of LY4065967 followed by a single dose of [14C]-LY4065967. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4065967 | Drug | Oral dose |
| |
| [14C]-LY4065967 Oral |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Percentage of Total Radioactive Dose in Urine and Fecal Excretion | Baseline through Study Completion (21 days) | |
| Part 2: Plasma Area Under the Concentration-time Curve from Zero to Infinity (AUC(0-ꝏ)) for LY4065967 | Baseline through Study Completion (9 Days) |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1 Pharmacokinetic (PK): Plasma AUC(0-ꝏ) for Total Radioactivity and LY4065967 | Baseline through Study Completion (21 days) | |
| Part 1 PK: Plasma Maximum Concentration (Cmax) for Total Radioactivity and LY4065967 | Baseline through Study Completion (21 days) |
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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 | Madison | Wisconsin | 53704 | United States |
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| Radiation |
Oral dose |
|
| [14C]-LY4065967 IV | Radiation | IV dose |
|
| Part 1 PK: Blood Total Radioactivity AUC | Baseline through Study Completion (21 days) |
| Part 1 PK: Blood Total Radioactivity Cmax | Baseline through Study Completion (21 days) |
| Part 1: Total Number and Identification of Metabolites | Baseline through Study Completion (21 days) |
| Part 2 PK: Plasma AUC(0-ꝏ) for Total Radioactivity, [14C]-LY4065967, and LY4065967 | Baseline through Study Completion (9 Days) |
| Part 2 PK: Plasma Cmax for Total Radioactivity, [14C]-LY4065967, and LY4065967 | Baseline through Study Completion (9 Days) |