A Study of LY3556050 in Healthy Participants

Phase 1

Completed

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

• Registration Number: NCT04156750
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to learn more about the safety of LY3556050 after it is given by mouth to healthy participants. Blood tests will be performed to check how much LY3556050 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive multiple doses of LY3556050 or placebo and will remain in the study for up to 31 days.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-06
• Study First Submitted QC: 2019-11-06
• Study First Posted: 2019-11-07
• Study Start: 2019-11-20
• Primary Completion: 2020-08-03
• Study Completion: 2020-08-03
• Status Verified: 2020-08-15
• Last Update Submitted: 2020-08-18
• Last Update Posted: 2020-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Healthy males or females of nonchild bearing potential, as determined by medical history
• Have safety laboratory results within normal references ranges
• Weight at least 50 kilograms (kg)

Exclusion Criteria

• Have known allergies to LY3556050, iodine, metformin and related compounds
• Abnormal electrocardiogram (ECG) or blood pressure at screening
• Significant history of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or endocrine disorders
• Show evidence of active renal disease with estimated glomerular filtration rate (GFR) <90 milliliters per minute per 1.73 meters squared

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3556050+ Iohexol (Part B)	LY3556050	Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.)
Placebo (Part A)	Placebo	Placebo administered orally.
LY3556050+ Iohexol (Part B)	Iohexol	Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.)
LY3556050 (Part A)	LY3556050	LY3556050 administered orally.
LY3556050 + Metformin (Part B)	LY3556050	Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.)
LY3556050 + Metformin (Part B)	Metformin	Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.)
Metformin (Part B)	Metformin	Metformin given orally. (Part B is optional.)
Iohexol (Part B)	Iohexol	Iohexol given intravenously (IV). (Part B is optional.)

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline through Final Follow-up (up to Week 9)]	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3556050	Baseline through Day 17	PK: Cmax of LY3556050
PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ)	Baseline through Day 17	PK: AUCτ of LY3556050

Trial Locations

Locations (1)

Covance; 🇺🇸 Dallas, Texas, United States