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| ID | Type | Description | Link |
|---|---|---|---|
| J5C-MC-FOAA | Other Identifier | DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company | |
| DCE853107 | Other Identifier | DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company |
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The main purpose of this study is to assess the safety and tolerability of LY4100511 (DC-853) after single and multiple dose administrations in healthy asian participants and non-Asian participants. Part A consists of 2 groups and Part B, C, and D include optional groups.
Part B and C added per protocol amendment (May 2024) Added Part B to explore higher dose levels and Part C to explore effects of food. Part D added per protocol amendment (June 2024) to explore higher multiple doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4100511 (DC-853) Part A Fasted | Experimental | Single and multiple doses of LY4100511 (DC-853) administered orally. |
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| LY4100511 (DC-853) Part B | Experimental | Single and multiple higher doses of LY4100511 (DC-853) administered orally. |
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| LY4100511 (DC-853) Part C (Open Label) | Experimental | Single dose of LY4100511 (DC-853) administered orally in fed and fasted states. |
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| LY4100511 (DC-853) Part D | Experimental | Multiple higher doses of LY4100511 (DC-853) administered orally. |
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| Placebo | Placebo Comparator | Placebo administered orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4100511 (DC-853) | Drug | Administered orally fasted |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with one or more Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. | Baseline up to 47 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4100511 (DC-853) | Predose up to 47 days | |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4100511 (DC-853) | Predose up to 47 days |
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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 |
|---|---|---|---|---|---|---|
| Altasciences Clinical Los Angeles, Inc | Cypress | California | 90630 | United States |
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| LY4100511 (DC-853) |
| Drug |
Administered orally fasted. |
|
| LY4100511 (DC-853) | Drug | Administered orally fed and fasted. |
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| LY4100511 (DC-853) | Drug | Administered orally fed and fasted. |
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| Placebo | Drug | Administered orally. |
|