A Relative Bioavailability Study of LY3209590 in Healthy Participants

Study Overview
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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.

Official Title
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Effect of Injection Site on the Relative Bioavailability of Single Dose of LY3209590 and Evaluation of Absolute Bioavailability of LY3209590 in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3209590 (SC)
* Drug: LY3209590 (IV)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Part A is Parallel design and Part B is a crossover design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3209590 (Part A - Upper Arm)<br>LY3209590 administered subcutaneously (SC) into the upper arm | Drug: LY3209590 (SC)<br>* Administered SC.<br>|
| Experimental: LY3209590 (Part A - Thigh)<br>LY3209590 administered SC into the thigh | Drug: LY3209590 (SC)<br>* Administered SC.<br>|
| Experimental: LY3209590 (Part A - Abdominal Wall)<br>LY3209590 administered SC into the abdominal wall | Drug: LY3209590 (SC)<br>* Administered SC.<br>|
| Experimental: LY3209590 (Part B - IV Dose)<br>LY3209590 administered intravenously (IV) | Drug: LY3209590 (IV)<br>* Administered IV.<br>|
| Experimental: LY3209590 (Part B - SC Dose)<br>LY3209590 administered SC into the abdominal wall | Drug: LY3209590 (SC)<br>* Administered SC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590 | Part A: PK: AUC0-∞ of LY3209590 | Predose on Day 1 through Day 65 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part B: PK: AUC0-∞ of LY3209590 | Part B: PK: AUC0-∞ of LY3209590 | Predose on Day 1 through Day 65 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bioavailability, Injection sites