A Study of LY3556050 in Healthy Participants

NCT04156750 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17612J2P-MC-LXBA
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  Baseline through Final Follow-up (up to Week 9)]

Secondary Outcomes (2)

• 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

Study Arms (6)

LY3556050 (Part A)

EXPERIMENTAL

LY3556050 administered orally.

Drug: LY3556050

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered orally.

Drug: Placebo

Iohexol (Part B)

OTHER

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

Drug: Iohexol

Metformin (Part B)

OTHER

Metformin given orally. (Part B is optional.)

Drug: Metformin

LY3556050+ Iohexol (Part B)

EXPERIMENTAL

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

Drug: LY3556050; Drug: Iohexol

LY3556050 + Metformin (Part B)

EXPERIMENTAL

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

Drug: LY3556050; Drug: Metformin

Interventions

LY3556050 DRUG

Administered orally.

LY3556050 (Part A); LY3556050 + Metformin (Part B); LY3556050+ Iohexol (Part B)

Placebo DRUG

Administered orally.

Placebo (Part A)

Iohexol DRUG

Administered IV.

Iohexol (Part B); LY3556050+ Iohexol (Part B)

Metformin DRUG

Administered orally.

LY3556050 + Metformin (Part B); Metformin (Part B)

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

Iohexol; Metformin

Intervention Hierarchy (Ancestors)

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

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Part A - Double-blind. Part B - Open label.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A - Parallel design. Part B - Open label design.

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 7, 2019
• Study Start: November 20, 2019
• Primary Completion: August 3, 2020
• Study Completion: August 3, 2020
• Last Updated: August 19, 2020

Record last verified: 2020-08-15

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)