A Relative Bioavailability Study 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

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-11

Study Completion Date

2023-06-28

Brief Summary

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The study will be conducted in two parts (part A and part B). The main purpose of this study is to compare the amount of LY3209590 that gets into the blood stream and how long it takes the body to get rid of it, when self-administered at different body sites, abdominal wall, upper arm and thigh (part A), when administered by two different routes of injection, subcutaneously or intravenously (part B) in healthy participants.

The study may last up to 65 (part A) and 184 (part B) days, respectively.

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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

PARALLEL

Part A is Parallel design and Part B is a crossover design

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3209590 (Part A - Upper Arm)

LY3209590 administered subcutaneously (SC) into the upper arm

Group Type EXPERIMENTAL

LY3209590 (SC)

Intervention Type DRUG

Administered SC.

LY3209590 (Part A - Thigh)

LY3209590 administered SC into the thigh

Group Type EXPERIMENTAL

LY3209590 (SC)

Intervention Type DRUG

Administered SC.

LY3209590 (Part A - Abdominal Wall)

LY3209590 administered SC into the abdominal wall

Group Type EXPERIMENTAL

LY3209590 (SC)

Intervention Type DRUG

Administered SC.

LY3209590 (Part B - IV Dose)

LY3209590 administered intravenously (IV)

Group Type EXPERIMENTAL

LY3209590 (IV)

Intervention Type DRUG

Administered IV.

LY3209590 (Part B - SC Dose)

LY3209590 administered SC into the abdominal wall

Group Type EXPERIMENTAL

LY3209590 (SC)

Intervention Type DRUG

Administered SC.

Interventions

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LY3209590 (SC)

Administered SC.

Intervention Type DRUG

LY3209590 (IV)

Administered IV.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female participants who are overtly healthy as determined by medical evaluation
* Participants with body mass index (BMI) within the range 18.5 to 35.0 kilograms per meter squared (kg/m²)
* Male or female participants must agree to use contraception

Exclusion Criteria

* Have a history of multiple or severe allergic reactions or a history of severe anaphylactic reaction
* Have known allergies to LY3209590, related compounds, or any components of the formulation
* Have an abnormality in the 12-lead electrocardiogram
* Intend to use prescription medication, including herbal medications and traditional medications
* Show evidence of human immunodeficiency virus infection or positive human immunodeficiency virus antibodies, hepatitis C or positive hepatitis C antibody, or hepatitis B or positive hepatitis B surface antigen
* Are lactating or pregnant

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes