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OpenTrials
Completed

NCT Number: NCT05615467

A Study of Effect of LY3556050 on Metformin in Healthy Participants

The main purpose of this study is to evaluate how much Metformin gets into the bloodstream and how long the body takes to get rid of it when it is administered orally in combination with LY3556050 in healthy participants. Iohexol will be administered to evaluate kidney function. Each enrolled participant will remain in the study for up to 7 weeks including the screening period.

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Key information

Conditions

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA International

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male and female participants who are overtly healthy as determined by medical evaluation
  • Participants with body weight of at least 50 kilograms (kg) or more and have a body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²)
  • Have an ECG at screening considered to be within acceptable limits by the investigator
  • Male participants who agree to use contraception and female participants of child bearing potential who agree to use contraception and women not of child bearing potential may participate.

Exclusion criteria

  • Women who are lactating
  • Have known allergies or contraindications to LY3556050, metformin, iodine, iohexol, or other contrast agents, related compounds or any components of their formulation, or history of significant atopy
  • Have a history, or ECG findings, of clinically significant bradycardia, heart block, tachycardia, sick sinus syndrome/sinoatrial block, first-degree AV block, or second- or third-degree AV block, bundle branch block or other tachy- or brady-arrhythmias; o rhave any other abnormality in the 12-lead ECG that, in the opinion of the investigator, confounds assessment of QT interval or increases the risks associated with participating in the study
  • Have active or a history of gastritis or peptic ulcer disease

Treatment and study plan

LY3556050

Drug

Administered orally.

metformin

Drug

Administered orally.

Iohexol

Drug

Administered IV.

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Metformin

    Time frame: Predose on day 1 through 13 days postdose

    PK: AUC of Metformin

  2. PK: Maximum Observed Drug Concentration (Cmax) of Metformin

    Time frame: Predose on day 1 through 13 days postdose

    PK: Cmax of Metformin

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

An Open-Label Study in Healthy Participants to Evaluate the Effect of LY3556050 on Metformin Pharmacokinetics

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 14, 2022
Registry last updated
Jan 18, 2023

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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