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A Study of LY3556050 in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04156750
Recruitment Status : Suspended (Enrollment on hold due to COVID-19 pandemic.)
First Posted : November 7, 2019
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: LY3556050 Drug: Placebo Drug: Iohexol Drug: Metformin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Part A - Parallel design. Part B - Open label design.
Masking: Double (Participant, Investigator)
Masking Description: Part A - Double-blind. Part B - Open label.
Primary Purpose: Basic Science
Official Title: Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study With LY3556050 in Healthy Subjects
Actual Study Start Date : November 20, 2019
Estimated Primary Completion Date : July 23, 2020
Estimated Study Completion Date : July 23, 2020

Arm Intervention/treatment
Experimental: LY3556050 (Part A)
LY3556050 administered orally.
Drug: LY3556050
Administered orally.

Placebo Comparator: Placebo (Part A)
Placebo administered orally.
Drug: Placebo
Administered orally.

Iohexol (Part B)
Iohexol given intravenously (IV). (Part B is optional.)
Drug: Iohexol
Administered IV.

Metformin (Part B)
Metformin given orally. (Part B is optional.)
Drug: Metformin
Administered orally.

Experimental: LY3556050+ Iohexol (Part B)
Iohexol given intravenously (IV) coadministered with oral doses of LY3556050. (Part B is optional.)
Drug: LY3556050
Administered orally.

Drug: Iohexol
Administered IV.

Experimental: LY3556050 + Metformin (Part B)
Metformin given orally coadministered with oral doses of LY3556050. (Part B is optional.)
Drug: LY3556050
Administered orally.

Drug: Metformin
Administered orally.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3556050 [ Time Frame: Baseline through Day 17 ]
    PK: Cmax of LY3556050

  2. PK: Area Under the Concentration Versus Time Curve During 1 Dosing Interval (AUCτ) [ Time Frame: Baseline through Day 17 ]
    PK: AUCτ of LY3556050



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156750


Locations
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United States, Texas
Covance
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04156750    
Other Study ID Numbers: 17612
J2P-MC-LXBA ( Other Identifier: Eli Lilly and Company )
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metformin
Hypoglycemic Agents
Physiological Effects of Drugs