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| ID | Type | Description | Link |
|---|---|---|---|
| J2P-MC-LXBB | Other Identifier | Eli Lilly and Company |
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The main purpose of this study is to conduct blood tests to measure how much LY3556050 is in the bloodstream and to determine if any age, gender, or food effects exist. The study will also evaluate the safety of LY3556050. This is a 2-part study. In Part 1, single increasing doses of LY3556050 will be given orally and participants will be confined for a 5-day period. In Part 2, multiple increasing doses of LY3556050 will be given orally and participants will be confined for a 14-day period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3556050 (Part 1) | Experimental | Participants will receive single ascending doses of LY3556050 orally. |
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| Placebo (Part 1) | Experimental | Participants will receive placebo orally. |
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| LY3556050 (Part 2) | Experimental | Participants will receive multiple ascending doses of LY3556050 orally. |
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| Placebo (Part 2) | Experimental | Participants will receive placebo orally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3556050 | Drug | Administered orally. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 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 through Day 30 |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3556050 (Part 1) | PK: Cmax of LY3556050 (Part 1) | Predose on day 1 until Day 3 (Cohorts 1 to 7), and Predose on Day 8 until Day 10 (Only for Cohort 7) |
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3556050 (Part 1) | PK: AUC[0-∞] of LY3556050 (Part 1) | Predose on day 1 until Day 3 (Cohorts 1 to 7), and Predose on Day 8 until Day 10 (Only for Cohort 7) |
| PK: Fraction of LY3556050 Excreted in 48-hour Urine (fe[0-48]) (Part 1) | PK: fe[0-48] of LY3556050 (Part 1) | Predose on day 1 until Day 3 (Cohort 7), and Predose on Day 8 until Day 10 (Cohort 7) |
| PK: Cmax of LY3556050 (Part 2) | PK: Cmax of LY3556050 (Part 2) | Predose up to Postdose on Day 10 |
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC[0-24]) of LY3556050 (Part 2) | PK: AUC[0-24] of LY3556050 (Part 2) | Predose up to Postdose on Day 10 |
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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 |
|---|---|---|---|---|---|---|
| Medpace Clinical Pharmacology, LLC | Cincinnati | Ohio | 45227 | United States |
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All the participants will be double blinded except for LY3556050 (Part 1) - Cohort 7 which will be open label.
| Placebo | Drug | Administered orally. |
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