A Study of Two Different Formulations of LY3209590 in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2021-09-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3209590 Lyophilized Formulation

LY3209590 as lyophilized formulation administered subcutaneously (SC) in one of the two study periods.

Group Type EXPERIMENTAL

LY3209590

Intervention Type DRUG

Administered SC.

LY3209590 Solution Formulation

LY3209590 as solution formulation administered SC in one of the two study periods.

Group Type EXPERIMENTAL

LY3209590

Intervention Type DRUG

Administered SC.

Interventions

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LY3209590

Administered SC.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes