A Study of LY3556050 in Healthy Participants

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.

Full Title of Study: “Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3556050 in Healthy Subjects”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 24, 2020

Interventions

  • Drug: LY3556050
    • Administered orally.
  • Drug: Placebo
    • Administered orally.
  • Drug: Iohexol
    • Administered IV.
  • Drug: Metformin
    • Administered orally.

Arms, Groups and Cohorts

  • Experimental: LY3556050 (Part A)
    • LY3556050 administered orally.
  • Placebo Comparator: Placebo (Part A)
    • Placebo administered orally.
  • Other: Iohexol (Part B)
    • Iohexol given intravenously (IV). (Part B is optional.)
  • Other: Metformin (Part B)
    • Metformin given orally. (Part B is optional.)
  • Experimental: LY3556050+ Iohexol (Part B)
    • Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.)
  • Experimental: LY3556050 + Metformin (Part B)
    • Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.)

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
    • Time Frame: 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 Measures

  • Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3556050
    • Time Frame: Baseline through Day 17
    • PK: Cmax of LY3556050
  • PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ)
    • Time Frame: Baseline through Day 17
    • PK: AUCτ of LY3556050

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • 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), Study Director, Eli Lilly and Company
  • Overall Contact(s)
    • This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or, 1-317-615-4559, ClinicalTrials.gov@Lilly.com

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