Study of LY3039478 in Healthy Participants

Study Overview
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Brief Summary
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The study involves one dose of LY3039478 given by mouth followed by an intravenous infusion (IV) (via a tube linked to a small needle in the vein) of LY3039478. The results of this study will help to answer the following research questions: How much LY3039478 gets into the blood stream when given by mouth as a capsule compared to when given by an IV How long it takes the body to remove the study drug The safety of LY3039478 and any side effects that might be associated with it Participation in the study is expected to last up to 7 weeks. There will be screening, a single study period, and a follow-up.

Official Title
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An Absolute Bioavailability Study of LY3039478 in Healthy Subjects Using the Intravenous Tracer Method

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3039478
* Drug: 3C 15N 2H-LY3039478 IV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Have a body mass index (BMI) of 18.5 to 32.0 kilogram per meter square (kg/m²) inclusive Exclusion Criteria: - Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product • Have known allergies to LY3039478, related compounds or any components of the formulation, or history of significant atopy in the opinion of the investigator

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3039478 - Oral<br>LY3039478 given once, orally | Drug: LY3039478<br>* Administered orally<br>|
| Experimental: 13C 15N 2H-LY3039478 - IV<br>13C 15N 2H-LY3039478 given once, IV | Drug: 3C 15N 2H-LY3039478 IV<br>* Administered IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area Under the Concentration versus Time Curve (AUC) from Time Zero to the Last Time Point with a Measurable Concentration (AUC[0 tlast]) of LY3039478 and 3C 15N 2H-LY3039478 |  | Predose through 48 hours after administration of study drug | 
| Pharmacokinetics: AUC from Zero to Infinity (AUC[0 - inf]) of LY3039478 and 3C 15N 2H-LY3039478 |  | Predose through 48 hours after administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY3039478 |  | Predose through 48 hours after administration of study drug | 
| Pharmacokinetics: Time of Cmax (tmax) of LY3039478 |  | Predose through 48 hours after administration of study drug | 
| Pharmacokinetics: Half Life Associated With The Terminal Rate Constant (t1/2) of LY3039478 |  | Predose through 48 hours after administration of study drug |