A Study of LY3556050 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3556050; Drug: Iohexol; Drug: Placebo; Drug: Metformin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04156750

17612

J2P-MC-LXBA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 6 patient groups, including a placebo group

LY3556050 (Part A)

Experimental group

Description:

LY3556050 administered orally.

Treatment:

Drug: LY3556050

Placebo (Part A)

Placebo Comparator group

Description:

Placebo administered orally.

Treatment:

Drug: Placebo

Iohexol (Part B)

Other group

Description:

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

Treatment:

Drug: Iohexol

Metformin (Part B)

Other group

Description:

Metformin given orally. (Part B is optional.)

Treatment:

Drug: Metformin

LY3556050+ Iohexol (Part B)

Experimental group

Description:

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

Treatment:

Drug: LY3556050

Drug: Iohexol

LY3556050 + Metformin (Part B)

Experimental group

Description:

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

Treatment:

Drug: LY3556050

Drug: Metformin