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| ID | Type | Description | Link |
|---|---|---|---|
| I8D-MC-AZEJ | Other Identifier | Eli Lilly and Company |
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Stopped for futility. Phase 3 studies not likely to meet primary endpoints.
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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The purpose of the study is to determine whether LY3314814 can be safely prescribed in participants with liver impairment without a dose adjustment. Participants will be on study for 11 days with follow-up about 7 days afterward.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3314814 Control | Experimental | LY3314814 administered orally to participants with normal hepatic function |
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| LY3314814 Mild | Experimental | LY3314814 administered orally to participants with mild hepatic impairment |
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| LY3314814 Moderate | Experimental | LY3314814 administered orally to participants with moderate hepatic impairment |
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| LY3314814 Severe | Experimental | LY3314814 administered orally to participants with severe hepatic impairment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3314814 | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of LY3314814 | PK: AUC(0-∞) of LY3314814 | Baseline through 240 hours after the administration of study drug |
| PK: Maximum Observed Drug Concentration (Cmax) of LY3314814 | PK: Cmax of LY3314814 | Baseline through 240 hours after the administration of study drug |
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Inclusion Criteria:
- Have a Body Mass Index (BMI) of 18 to 40 kilogram per meter square (kg/m²), inclusive, at the time of screening
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 |
|---|---|---|---|---|---|---|
| Orange County Research Center | Tustin | California | 92780 | United States | ||
| Clinical Pharmacology of Miami |
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| Miami |
| Florida |
| 33014 |
| United States |
| Orlando Clinical Research Ctr | Orlando | Florida | 32809 | United States |
| New Orleans Cntr for Clin Res | Knoxville | Tennessee | 37920 | United States |