A Study of Effect of LY3556050 on Metformin in Healthy Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT05615467

Collaborator

(none)

Enrollment

Location

Arm

1.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3556050 Drug: Metformin Drug: Iohexol	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Nov 15, 2022

Actual Primary Completion Date :

Dec 27, 2022

Actual Study Completion Date :

Dec 27, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3556050 + Metformin + Iohexol LY3556050 administered orally in combination with metformin given orally and iohexol given intravenously (IV).	Drug: LY3556050 Administered orally. Drug: Metformin Administered orally. Drug: Iohexol Administered IV.

Arm

Intervention/Treatment

Experimental: LY3556050 + Metformin + Iohexol

LY3556050 administered orally in combination with metformin given orally and iohexol given intravenously (IV).

Drug: LY3556050

Administered orally.

Drug: Metformin

Administered orally.

Drug: Iohexol

Administered IV.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRA International	Salt Lake City	Utah	United States	84124

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT05615467

Other Study ID Numbers:

18629
J2P-MC-LXBE

First Posted:

Nov 14, 2022

Last Update Posted:

Jan 18, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Metformin

Study Results

No Results Posted as of Jan 18, 2023