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A Study of Two Different Formulations of LY3209590 in Healthy Participants

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Lilly

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: LY3209590

Study type

Interventional

Funder types

Industry

Identifiers

NCT04768842
2020-003738-19 (EudraCT Number)
I8H-MC-BDCJ (Other Identifier)
16494

Details and patient eligibility

About

The main purpose of this study is to look at the amount of the study drug, LY3209590, that gets into the blood stream and how long it takes the body to get rid of LY3209590 when given as different formulations. The tolerability of LY3209590 will also be evaluated and information about any side effects experienced will be collected. The study will last up to 142 days.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Are overtly healthy males or non-pregnant females. Additionally, women of childbearing potential must test negative for pregnancy
  • Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m²), inclusive at screening
  • Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
  • Have veins suitable for blood sampling
  • Have given written informed consent approved by Lilly and the ethical review board governing the site

Exclusion criteria

  • Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
  • Are women who are pregnant or lactating
  • Have a history of multiple and/or severe allergic reactions
  • Show clinical evidence of HIV, hepatitis C, or hepatitis B, and/or test positive
  • Regularly use known drugs of abuse or with positive drug results

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

50 participants in 2 patient groups

LY3209590 Lyophilized Formulation
Experimental group
Description:
LY3209590 as lyophilized formulation administered subcutaneously (SC) in one of the two study periods.
Treatment:
Drug: LY3209590
LY3209590 Solution Formulation
Experimental group
Description:
LY3209590 as solution formulation administered SC in one of the two study periods.
Treatment:
Drug: LY3209590

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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