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| ID | Type | Description | Link |
|---|---|---|---|
| J6M-MC-JSGG | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to find out how much LY4064809 gets into the blood stream and how long it takes the body to get rid of it when it is given as two formulations. For each participant, the study will last about nine weeks. Participants will remain in the clinical research center for about one month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4064809 Test | Experimental | LY4064809 test (Phase 3 formulation) formulation administered orally in one of two periods. |
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| LY4064809 Reference | Experimental | LY4064809 reference (Phase 1 formulation) formulation administered orally in one of two periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4064809 Test Formulation | Drug | Administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809 | PK: Cmax of LY4064809 | Predose on Day 1 Through Day 28 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY4064809 | PK: AUC of LY4064809 | Predose on Day 1 Through Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee):
Have an abnormal electrocardiogram (ECG) at screening or admission
History of a major surgical procedure within 30 days prior to screening
Diagnosed or treated cancer within 5 years prior to screening, with the exception of the following cancers cured through treatment: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and in situ carcinoma of the cervix cured through surgery
Have used or plan to use medication within 14 days prior to admission, or plan to use during the study with the exception of acetaminophen
Have creatinine lab clearance less than 90mL/min calculated using the Cockroft-Gault equation at screening
Have a positive Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody or human immunodeficiency virus 1 and 2 antibody results at the screening visit
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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 Inc. - Madison | Madison | Wisconsin | 53704-2526 | United States |
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| ID | Term |
|---|---|
| C000730635 | STX-478 |
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| LY4064809 Reference Formulation | Drug | Administered orally |
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