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| ID | Type | Description | Link |
|---|---|---|---|
| J6V-MC-OIAB | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to assess the safety and tolerability of LY4515100 when given orally to healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last up to 30 days and will include six overnight stays.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4515100 of Part A (SAD) | Experimental | Single-ascending doses of LY4515100 will be given orally |
|
| LY4515100 of Part B (MAD) | Experimental | Multiple-ascending doses of LY4515100 will be given orally |
|
| Placebo Part A | Placebo Comparator | Placebo will be given orally |
|
| Placebo Part B | Placebo Comparator | Placebo will be given orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4515100 via SAD | Drug | given orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with one or more serious adverse event(s) (SAEs) of LY4515100 | SAEs of LY4515100 | Day 1 up to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY4515100 | PK: AUC of LY4515100 | Day 1 through Day 11 |
| PK: Maximum Observed Drug Concentration (Cmax) of LY4515100 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Contact Lilly at 1-877-CTLILLY (1-877-285-4559) or | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit | Recruiting | Dallas | Texas | 75247 | United States |
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| LY4515100 via MAD |
| Drug |
given orally |
|
PK: Cmax of LY4515100
| Time Frame: Day 1 through Day 11 |
| PK: Time of maximum observed drug concentration (tmax) of LY4515100 | PK: tmax of LY4515100 | Day 1 through Day 11 |