A Study of LY2801653 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, LY2801653 (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 increase understanding about how the drug appears in the blood, urine, and stool after it is administered to healthy people. Information about any side effects that may occur will also be collected. This study will last up to 15 days for each participant, not including screening. Screening is required within 28 days prior to enrollment.

Official Title
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Disposition of [^14C]-LY2801653 Following Oral Administration in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: [^14C]-LY2801653


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Generally healthy sterile male and female participants Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m^2), inclusive Exclusion Criteria: Regularly use known drugs of abuse and/or show positive findings on urinary drug screening Have consumed herbal supplements, grapefruit juice, grapefruits, grapefruit containing products, Seville orange juice, Seville oranges, star fruit, or star fruit juice within 7 days prior to dosing or intend to consume during the study Have donated blood of more than 500 milliliter (mL) within the last month Have participated in a [14C]-study within the last 6 months prior to admission for this study Exposure to significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) Have a defecation pattern less than once per 2 days or acute constipation within 3 weeks of day before dosing

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [^14C]-LY2801653<br>Single oral dose of LY2801653 containing 100 micro curies of radioactivity | Drug: [^14C]-LY2801653<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 LY2801653 Radioactivity over Time expressed as a Percentage of the Total Radioactive Dose Administered |  | Pre-dose up to 14 days post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Pharmacokinetics of LY2801653 and Radioactivity Maximum Observed Concentration (Cmax) |  | Pre-dose up to 14 days post dose | 
| Plasma Pharmacokinetics of LY2801653 and Radioactivity Time of Maximum Concentration (tmax) |  | Pre-dose up to 14 days post dose | 
| Plasma Pharmacokinetics of LY2801653 and Radioactivity Area Under The Concentration-time Curve from zero to the last timepoint with a measurable Concentration (AUC 0 to tlast) |  | Pre-dose up to 14 days post dose | 
| Relative Abundance of LY2801653 and the Metabolites of LY2801653 in Urine and Feces |  | Pre-dose up to 14 days post dose | 
| Relative Abundance of LY2801653 and the Metabolites of LY2801653 in Plasma |  | Pre-dose up to 14 days post dose |