A Study of LY3556050 in Healthy Participants

NCT ID: NCT04156750

Last Updated: 2020-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-20

Study Completion Date

2020-08-03

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Part A - Parallel design. Part B - Open label design.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

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

Study Groups

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LY3556050 (Part A)

LY3556050 administered orally.

Group Type EXPERIMENTAL

LY3556050

Intervention Type DRUG

Administered orally.

Placebo (Part A)

Placebo administered orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally.

Iohexol (Part B)

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

Group Type OTHER

Iohexol

Intervention Type DRUG

Administered IV.

Metformin (Part B)

Metformin given orally. (Part B is optional.)

Group Type OTHER

Metformin

Intervention Type DRUG

Administered orally.

LY3556050+ Iohexol (Part B)

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

Group Type EXPERIMENTAL

LY3556050

Intervention Type DRUG

Administered orally.

Iohexol

Intervention Type DRUG

Administered IV.

LY3556050 + Metformin (Part B)

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

Group Type EXPERIMENTAL

LY3556050

Intervention Type DRUG

Administered orally.

Metformin

Intervention Type DRUG

Administered orally.

Interventions

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LY3556050

Administered orally.

Intervention Type DRUG

Placebo

Administered orally.

Intervention Type DRUG

Iohexol

Administered IV.

Intervention Type DRUG

Metformin

Administered orally.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Covance

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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J2P-MC-LXBA

Identifier Type: OTHER

Identifier Source: secondary_id

17612

Identifier Type: -

Identifier Source: org_study_id

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