A Study of LY3556050 in Healthy Participants
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT04156750
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3556050+ Iohexol (Part B) LY3556050 Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.) Placebo (Part A) Placebo Placebo administered orally. LY3556050+ Iohexol (Part B) Iohexol Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.) LY3556050 (Part A) LY3556050 LY3556050 administered orally. LY3556050 + Metformin (Part B) LY3556050 Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.) LY3556050 + Metformin (Part B) Metformin Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.) Metformin (Part B) Metformin Metformin given orally. (Part B is optional.) Iohexol (Part B) Iohexol Iohexol given intravenously (IV). (Part B is optional.)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Covance
🇺🇸Dallas, Texas, United States