A Study of LY3556050 in Healthy Participants

Eli Lilly and Company34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

LY3556050DRUG

Administered orally.

PlaceboDRUG

Administered orally.

IohexolDRUG

Administered IV.

Metformin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Covance

Dallas, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: Baseline through Final Follow-up (up to Week 9)]

Secondary Outcomes

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3556050

PK: Cmax of LY3556050

Time frame: Baseline through Day 17

PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ)

PK: AUCτ of LY3556050

Time frame: Baseline through Day 17

Data from ClinicalTrials.gov

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