A Study of the Absorption, Distribution, Metabolism and Excretion of LY3039478 in Healthy Participants

Study Overview
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Brief Summary
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This type of study is called a radiolabeled study. For this study, LY3039478 (study drug) has been specially prepared to contain radiolabeled carbon [¹⁴C]. [¹⁴C] is a naturally occurring radioactive form of the element carbon. This study will help determine how the drug appears in the blood, urine, and stool after it is administered by mouth to healthy people. Information about any side effects that may occur will also be collected. This study will last about 10 weeks for each participant.

Official Title
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Disposition of [¹⁴C₂]-Labeled LY3039478 Following Oral Administration in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3039478


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m²), inclusive Exclusion Criteria: Have previously completed or withdrawn from this study or any other study investigating LY3039478, and have previously received the investigational product Have known allergies to LY3039478, related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 Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing (eg, serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) Have participated in a [¹⁴C] study within the last 6 months prior to admission for this study. The total 12-month exposure from this study and a maximum of one other previous [¹⁴C]-study within 6 to 12 months of this study must be within the Code of Federal Regulations (CFR) recommended levels considered safe: less than 5000 millirem (mrem)/year whole body annual exposure

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiolabelled LY3039478<br>Single dose of radiolabelled LY3039478 administered orally. | Drug: LY3039478<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary and Fecal Excretion of Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |  | Predose up to 168 hours after administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3039478 |  | Predose through 168 hours postdose | 
| Pharmacokinetics: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Total Plasma Radioactivity |  | Predose through 168 hours postdose | 
| Pharmacokinetics: Maximum Observed Concentration (Cmax) of LY3039478 |  | Predose through 168 hours postdose | 
| Pharmacokinetics: Maximum Observed Concentration (Cmax) of Total Plasma Radioactivity |  | Predose through 168 hours postdose | 
| Total Number of Metabolites of LY3039478 in Plasma, Urine and Feces |  | Predose through 168 hours postdose |