A Study of Effect of LY3556050 on Metformin in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3556050; Drug: Metformin; Drug: Iohexol

• Registration Number: NCT05615467
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-11
• Study First Submitted QC: 2022-11-11
• Study First Posted: 2022-11-14
• Study Start: 2022-11-15
• Primary Completion: 2022-12-27
• Study Completion: 2022-12-27
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY3556050 + Metformin + Iohexol	LY3556050	LY3556050 administered orally in combination with metformin given orally and iohexol given intravenously (IV).
LY3556050 + Metformin + Iohexol	Iohexol	LY3556050 administered orally in combination with metformin given orally and iohexol given intravenously (IV).
LY3556050 + Metformin + Iohexol	Metformin	LY3556050 administered orally in combination with metformin given orally and iohexol given intravenously (IV).

Primary Outcome Measures

Name	Time	Method
PK: Maximum Observed Drug Concentration (Cmax) of Metformin	Predose on day 1 through 13 days postdose	PK: Cmax of Metformin
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Metformin	Predose on day 1 through 13 days postdose	PK: AUC of Metformin

Trial Locations

Locations (1)

PRA International; 🇺🇸 Salt Lake City, Utah, United States