A Study of Effect of LY3556050 on Metformin in Healthy Participants

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3556050
* Drug: Metformin
* Drug: Iohexol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3556050 + Metformin + Iohexol<br>LY3556050 administered orally in combination with metformin given orally and iohexol given intravenously (IV). | Drug: LY3556050<br>* Administered orally.<br>Drug: Metformin<br>* Administered orally.<br>Drug: Iohexol<br>* Administered IV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Metformin | PK: AUC of Metformin | Predose on day 1 through 13 days postdose | 
| PK: Maximum Observed Drug Concentration (Cmax) of Metformin | PK: Cmax of Metformin | Predose on day 1 through 13 days postdose |