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| ID | Type | Description | Link |
|---|---|---|---|
| I6A-EW-CBBB | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to measure how much LY3023414 (a test formulation and a reference formulation) gets into the blood stream and how long it takes the body to get rid of it.
The study will also evaluate the effects of a high fat meal on LY3023414 compared to taking LY3023414 on an empty stomach. In addition, the tolerability of the study drug formulations will be evaluated. Information about any side effects that may occur will be collected.
This study includes 3 periods. Participants will be admitted to the clinical research unit (CRU) one day before dosing in each period. Total study duration is about 21 days, including follow-up. Screening may occur up to 30 days before the first dose of study drug.
This study is for research purposes only and is not intended to treat any medical conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3023414 Reference Fasted | Experimental | Single oral dose of LY3023414 (Reference) on day one fasting. |
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| LY3023414 Test Fasted | Experimental | Single oral dose of LY3023414 (Test) on day one fasting. |
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| LY3023414 Test Fed | Experimental | Single oral dose of LY3023414 (Test) on day one after a meal. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3023414 Reference Fasted | Drug | Administered Orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area under the concentration versus time curve (AUC) from time zero to infinity (AUC[0-inf]) of LY3023414 | Pre-dose through 2 days post-dose in each period | |
| Pharmacokinetics (PK): Area under the concentration from time zero to time t, where t is the last time point with a measurable concentration (AUC [0-tlast]) of LY3023414 | Pre-dose through 2 days post-dose in each period | |
| Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3023414 | Pre-dose through 2 days post-dose in each period | |
| Pharmacokinetics (PK): Observed time of maximum concentration (tmax) | Pre-dose through 2 days post-dose in each period |
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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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Inc | Daytona Beach | Florida | 32117 | United States |
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| LY3023414 Test Fasted |
| Drug |
Administered Orally |
|
| LY3023414 Test Fed | Drug | Administered Orally |
|