A Study of Effect of LY3556050 on Metformin in Healthy Participants

NCT05615467 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18629J2P-MC-LXBE
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

LY3556050 + Metformin + Iohexol

EXPERIMENTAL

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

Drug: LY3556050; Drug: Metformin; Drug: Iohexol

Interventions

LY3556050 DRUG

Administered orally.

LY3556050 + Metformin + Iohexol

Metformin DRUG

Administered orally.

LY3556050 + Metformin + Iohexol

Iohexol DRUG

Administered IV.

LY3556050 + Metformin + Iohexol

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

PRA International

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Interventions

Metformin; Iohexol

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 14, 2022
• Study Start: November 15, 2022
• Primary Completion: December 27, 2022
• Study Completion: December 27, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)