A Study to Compare Two Formulations of LY3209590 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to compare the two formulations of LY3209590 in healthy participants. Study participants will be administered each formulation at separate study visits. Blood samples will be taken to compare how the body handles study drugs. The information about any adverse effects experienced will be collected and the tolerability of LY3209590 will also be evaluated. Screening is required within 28 days prior to enrolment. For each participant, the total duration of the clinical trial will be about 184 days including screening.

Official Title
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A Bioequivalence Study of Subcutaneous Injections of LY3209590 in Two Formulations in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3209590 (Formulation 1)
* Drug: LY3209590 (Formulation 2)


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 Have a body weight of 45 kilograms or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²), inclusive Contraceptive use by participants should be consistent with local regulations Exclusion Criteria: Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs Have known allergies to LY3209590, related compounds, or any components of the formulation Have a history of multiple or severe allergic reactions or a history of severe anaphylactic reaction Have an abnormality in the 12-lead electrocardiogram (ECG) 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3209590 (Formulation 1)<br>Single dose of LY3209590 as formulation 1 administered subcutaneously (SC). | Drug: LY3209590 (Formulation 1)<br>* Administered SC.<br>|
| Experimental: LY3209590 (Formulation 2)<br>Single dose of LY3209590 as formulation 2 administered SC. | Drug: LY3209590 (Formulation 2)<br>* Administered SC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the Last Time Point (AUC[0-tlast]) of LY3209590 | PK: AUC(0-tlast) of LY3209590 | Predose up to 65 days post dose | 
| PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590 | PK: AUC(0-∞) of LY3209590 | Predose up to 65 days post dose | 
| PK: Maximum Observed Concentration (Cmax) of LY3209590 | PK: Cmax of LY3209590 | Predose up to 65 days post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Formulation, Bioavailability