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A Study of LY3556050 in Healthy Participants

Phase 1
Completed
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
LY3556050+ Iohexol (Part B)LY3556050Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.)
Placebo (Part A)PlaceboPlacebo administered orally.
LY3556050+ Iohexol (Part B)IohexolIohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.)
LY3556050 (Part A)LY3556050LY3556050 administered orally.
LY3556050 + Metformin (Part B)LY3556050Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.)
LY3556050 + Metformin (Part B)MetforminMetformin given orally coadministered with oral doses of LY3556050. (Part B is optional.)
Metformin (Part B)MetforminMetformin given orally. (Part B is optional.)
Iohexol (Part B)IohexolIohexol given intravenously (IV). (Part B is optional.)
Primary Outcome Measures
NameTimeMethod
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug AdministrationBaseline 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
NameTimeMethod
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3556050Baseline 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

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