A Relative Bioavailability Study of LY3454738 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to look at the amount of the study drug, LY3454738 that gets into the blood stream and how long it takes the body to get rid of it when given under the skin comparing a test formulation versus a reference formulation in healthy participants. The study will also evaluate the safety and tolerability of LY3454738 and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately up to 17 weeks, including screening period.

Official Title
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A Phase 1, Open-Label Study to Determine the Relative Bioavailability of LY3454738 in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3454738


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who are overtly healthy as determined by medical history and physical examination. Have body mass index (BMI) between 18.0 and 28.0 kilograms per meter squared (kg/m²), inclusive, at screening. Exclusion Criteria: Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational medicinal product; or of interfering with the interpretation of data. Had any surgical procedure (except for minor surgery requiring local or no anesthesia and without any complications or sequelae) within 12 weeks prior to screening or intend to during the study. Show evidence of active or latent TB. Have one of the following infections: hepatitis B virus or human immunodeficiency virus (HIV). Participants must not be currently participating in or completed a clinical trial within the last 30 days

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3454738 (Test Formulation)<br> | Drug: LY3454738<br>* Administered subcutaneously (SC)<br>|
| Experimental: LY3454738 (Reference Formulation)<br> | Drug: LY3454738<br>* Administered subcutaneously (SC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3454738 | PK: Cmax of LY3454738 | Predose on day 1 up to 85 days post dose | 
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3454738 | PK: AUC of LY3454738 | Predose on day 1 up to 85 days post dose |