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OpenTrials
Completed

NCT Number: NCT04156750

A Study of LY3556050 in Healthy Participants

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance

Dallas, Texas, 75247, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3556050

Drug

Administered orally.

Placebo

Drug

Administered orally.

Iohexol

Drug

Administered IV.

metformin

Drug

Administered orally.

Primary outcomes

  1. 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 outcomes

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

    Time frame: Baseline through Day 17

    PK: Cmax of LY3556050

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

    Time frame: Baseline through Day 17

    PK: AUCτ of LY3556050

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3556050 in Healthy Subjects

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 7, 2019
Registry last updated
Aug 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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