Study of LY3154207 in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will involve a single dose of 14C radiolabelled LY3154207. This means that a radioactive substance C14 will be incorporated into the study drug, to investigate the study drug and its breakdown products, to find out how much of these pass from blood into urine, feces and expired air. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.

Official Title
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Disposition of [14C]-LY3154207 Following Oral Administration in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3154207
* Drug: [14C]-LY3154207


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a body mass index (BMI) of 19 to 32.0 kilogram per meter square (kg/m²) Are 18 to 50 years old, inclusive, at the time of screening Exclusion Criteria: Are currently or have been smokers or users of tobacco or nicotine replacement products within the 3 months prior to admission and/or have positive cotinine at screening or check-in Are unwilling to refrain from consuming caffeine- or xanthine-containing food and drink from 48 hours prior to admission and while resident in the CRU Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study Have participated in a [14C]-study within the last 4 to 6 months prior to admission for this study. The total 12-month exposure from this study and a maximum of 1 other previous [14C]-study within 6 to 12 months of this study (if the previous studies' radiation exposure is not known) or a maximum of 2 other previous [14C]-studies within 4 to 12 months of this study Have a history of clinically significant adverse drug reactions or drug allergy to more than 3 types of systemically administered medications (all penicillins and cephalosporins may be considered 1 type of medication for this purpose)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

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: LY3154207 and [14C]-LY3154207<br>A single dose of LY3154207 and [14C]-LY3154207administered orally. | Drug: LY3154207<br>* Administered orally<br>Drug: [14C]-LY3154207<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Urinary Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Baseline through 552 hours after administration of study drug | 
| Fecal Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Fecal Excretion of LY3154207 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered | Baseline through 552 hours after administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207 | Pharmacokinetics: Cmax of LY3154207 | Predose through 144 hours after administration of study drug | 
| Pharmacokinetics: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) | Pharmacokinetics: AUC(0-∞) | Predose through 144 hours after administration of study drug | 
| Total Number of Metabolites | Total Number of Metabolites | Baseline through 552 hours after administration of study drug |