Healthy
Conditions
Brief summary
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.
Interventions
DRUGLY3556050
Administered orally.
DRUGPlacebo
Administered orally.
DRUGIohexol
Administered IV.
DRUGMetformin
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Part A - Double-blind. Part B - Open label.
Intervention model description
Part A - Parallel design. Part B - Open label design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males or females of nonchild bearing potential, as determined by medical history * Have safety laboratory results within normal references ranges * Weight at least 50 kilograms (kg)
Exclusion criteria
* Have known allergies to LY3556050, iodine, metformin and related compounds * Abnormal electrocardiogram (ECG) or blood pressure at screening * Significant history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or endocrine disorders * Show evidence of active renal disease with estimated glomerular filtration rate (GFR) \<90 milliliters per minute per 1.73 meters squared
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline through Final Follow-up (up to Week 9)] | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3556050 | Baseline through Day 17 | PK: Cmax of LY3556050 |
| PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) | Baseline through Day 17 | PK: AUCτ of LY3556050 |
Countries
United States
Outcome results
None listed