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Clinical Trials/NCT04156750
NCT04156750CompletedPhase 1

Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3556050 in Healthy Subjects

Eli Lilly and Company1 site in 1 country34 target enrollmentStarted: November 20, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
34
Locations
1
Primary Endpoint
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Masking Description

Part A - Double-blind. Part B - Open label.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Metformin (Part B)

Other

Metformin given orally. (Part B is optional.)

Intervention: Metformin (Drug)

LY3556050 (Part A)

Experimental

LY3556050 administered orally.

Intervention: LY3556050 (Drug)

Placebo (Part A)

Placebo Comparator

Placebo administered orally.

Intervention: Placebo (Drug)

Iohexol (Part B)

Other

Iohexol given intravenously (IV). (Part B is optional.)

Intervention: Iohexol (Drug)

LY3556050+ Iohexol (Part B)

Experimental

Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.)

Intervention: LY3556050 (Drug)

LY3556050+ Iohexol (Part B)

Experimental

Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.)

Intervention: Iohexol (Drug)

LY3556050 + Metformin (Part B)

Experimental

Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.)

Intervention: LY3556050 (Drug)

LY3556050 + Metformin (Part B)

Experimental

Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.)

Intervention: Metformin (Drug)

Outcomes

Primary Outcomes

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time Frame: 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 Outcomes

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

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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