A Study to Compare Two Formulations of LY3819469 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to assess two formulations of LY3819469 based on the amount that gets into the blood stream and how long it takes the body to get rid of it, when given to healthy participants. The information about any adverse effects experienced will be collected and the tolerability of LY3819469 will also be evaluated. Screening is required within 28 days prior to the enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening and follow-up periods.

Official Title
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A Single Dose Study to Assess the Pharmacokinetics of 2 Formulations of LY3819469 in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3819469


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female participants who are overtly healthy as determined by medical evaluation Have a body mass index (BMI) in the range of 18.5 to 35.0 kilogram per square meter (kg/m²), inclusive at the time of screening Are male or women not of childbearing potential Exclusion Criteria: Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that could affect interpretation of study data Have any abnormality in the 12-lead electrocardiogram (ECG) Are heavy alcohol drinkers or heavy cigarette smokers Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives, or 30 days, whichever is longer, should have passed prior to CRU admission Have lost or donated blood of more than 450 mililitres (mL) within 3 months

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3819469 (Reference)<br>LY3819469 administered subcutaneously (SC). | Drug: LY3819469<br>* Administered SC.<br>|
| Experimental: LY3819469 (Test)<br>LY3819469 administered SC. | Drug: LY3819469<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 Timepoint with Measurable Concentration (AUC[0-tlast]) of LY3819469 | PK: AUC[0-tlast] of LY3819469 | Predose on day 1 up to postdose on day 85 | 
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819469 | PK: AUC[0-∞] of LY3819469 | Predose on day 1 up to postdose on day 85 | 
| PK: Maximum Observed Concentration (Cmax) of LY3819469 | PK: Cmax of LY3819469 | Predose on day 1 up to postdose on day 85 |