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A Study of LY3556050 in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04156750
Collaborator
(none)
34
Enrollment
1
Location
6
Arms
8.4
Actual Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Part A - Parallel design. Part B - Open label design.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 :
Nov 20, 2019
Actual Primary Completion Date :
Aug 3, 2020
Actual Study Completion Date :
Aug 3, 2020

Arms and Interventions

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.
Other: Iohexol (Part B)

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

Drug: Iohexol
Administered IV.
Other: 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.

Outcome Measures

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 [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 [Baseline through Day 17]

    PK: Cmax of LY3556050

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

    PK: AUCτ of LY3556050

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Covance Dallas Texas United States 75247

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04156750
Other Study ID Numbers:
  • 17612
  • J2P-MC-LXBA
First Posted:
Nov 7, 2019
Last Update Posted:
Aug 19, 2020
Last Verified:
Aug 15, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Metformin

Study Results

No Results Posted as of Aug 19, 2020