Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J2P-MC-LXBA | Other Identifier | Eli Lilly and Company |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to learn more about the safety of LY3556050 after it is given by mouth to healthy participants. Blood tests will be performed to check how much LY3556050 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive multiple doses of LY3556050 or placebo and will remain in the study for up to 31 days.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3556050 (Part A) | Experimental | LY3556050 administered orally. |
|
| Placebo (Part A) | Placebo Comparator | Placebo administered orally. |
|
| Iohexol (Part B) | Other | Iohexol given intravenously (IV). (Part B is optional.) |
|
| Metformin (Part B) | Other | Metformin given orally. (Part B is optional.) |
|
| LY3556050+ Iohexol (Part B) | Experimental | Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.) |
|
| LY3556050 + Metformin (Part B) | Experimental | Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3556050 | Drug | Administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Final Follow-up (up to Week 9)] |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3556050 | PK: Cmax of LY3556050 | Baseline through Day 17 |
| PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCĪ) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Dallas | Texas | 75247 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007472 | Iohexol |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
Not provided
Not provided
Part A - Parallel design. Part B - Open label design.
Not provided
Not provided
Part A - Double-blind. Part B - Open label.
|
| Placebo | Drug | Administered orally. |
|
| Iohexol | Drug | Administered IV. |
|
| Metformin | Drug | Administered orally. |
|
PK: AUCĪ of LY3556050
| Baseline through Day 17 |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |