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| ID | Type | Description | Link |
|---|---|---|---|
| I6A-EW-CBBC | Other Identifier | Eli Lilly and Company |
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This type of study is called a radiolabeled study. For this study, LY3023414 has been specially prepared to contain the radioactive carbon atom [¹⁴C]. [¹⁴C] is a naturally occurring radioactive form of the element carbon. Adding a low dose of radiation to the study drug does not change how the drug works but helps to identify when the drug appears in the blood, urine, breath, and stool after it is given. The study will last about 15 days for each participant, not including screening. Screening is required within 28 days prior to enrollment. This study is for research purposes only and is not intended to treat any medical condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [¹⁴C]-LY3023414 | Experimental | Single oral dose of [¹⁴C]-LY3023414 administered on Day 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [¹⁴C]-LY3023414 | Drug | LY3023414 in solution containing approximately 100 microCi [¹⁴C]-LY3023414 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Excretion of LY3023414 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Baseline up to 144 hours postdose | |
| Fecal Excretion of LY3023414 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Baseline up to 144 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Pharmacokinetics of LY3023414 and Radioactivity Maximum Observed Concentration (Cmax) | Baseline up to 144 hours postdose | |
| Plasma Pharmacokinetics of LY3023414 and Radioactivity Time of Maximum Observed Concentration (Tmax) | Baseline up to 144 hours postdose |
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Inclusion Criteria:
Healthy men or women
Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter square (kg/m²)
Have clinical laboratory test results within normal reference range for the population or investigator site
Have venous access sufficient to allow for blood sampling
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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Inc | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| C000621566 | LY3023414 |
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| Plasma Pharmacokinetics of LY3023414 and Radioactivity Area Under the Concentration Versus Time Curve (AUC) | Baseline up to 144 hours postdose |
| Relative Abundance of LY3023414 and the Metabolites of LY3023414 as Measured by Percentage of Sample Radioactivity in Plasma, Feces, Urine | Baseline up to 144 hours postdose |