A Study of Effect of LY3556050 on Metformin in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05615467
• Other study ID #: 18629
• Secondary ID: J2P-MC-LXBE
• Status: Completed
• Phase: Phase 1
• Start date: November 15, 2022
• Est. completion date: December 27, 2022

Study information

• Verified date: January 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 27, 2022
• Est. primary completion date: December 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3556050
Administered orally.
• Metformin
Administered orally.
• Iohexol
Administered IV.

Locations

Country	Name	City	State
United States	PRA International	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Metformin	PK: AUC of Metformin	Predose on day 1 through 13 days postdose
Primary	PK: Maximum Observed Drug Concentration (Cmax) of Metformin	PK: Cmax of Metformin	Predose on day 1 through 13 days postdose