A Study of LY2801653 in Healthy Participants Who Are Not Able to Have Children

Study Overview
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Brief Summary
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The purpose of this study is to evaluate how much of the LY2801653 drug is available in the body when given in 2 different formulations with and without a meal to healthy participants who are not able to have children. In addition, this study will measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The study will last about 27 days. Screening is required within 28 days prior to the start of the study.

Official Title
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Relative Bioavailability and the Effect of Food on the Bioavailability of LY2801653 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY2801653


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Generally healthy sterile male and female participants Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m^2), inclusive Are willing and able to eat the protocol specified high-fat breakfast Exclusion Criteria: Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange juice, star fruit, star fruit juice, or star fruit-containing products, or commercial apple or orange juice within 14 days prior to first dosing Regularly use known drugs of abuse and/or show positive findings on urinary drug screening Have donated blood of more than 500 milliliter (mL) within the last month

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY2801653 Reference - Fasted<br>Single oral dose of LY2801653 (Reference Formulation) administered in fasted state in one of three study periods. | Drug: LY2801653<br>* Administered orally<br>|
| Experimental: LY2801653 Test - Fasted<br>Single oral dose of LY2801653 (Test Formulation) administered in fasted state in one of three study periods. | Drug: LY2801653<br>* Administered orally<br>|
| Experimental: LY2801653 Test - Fed<br>Single oral dose of LY2801653 (Test Formulation) administered with a high fat meal in one of three study periods. | Drug: LY2801653<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Concentration (Cmax) for LY2801653 |  | Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3 | 
| Pharmacokinetics: Area Under the Concentration Curve (AUC 0-∞) for LY2801653 |  | Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2801653 and Major Metabolites LSN2800870 and LSN2887652 |  | Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3 | 
| Pharmacokinetics: Area Under the Concentration Curve (AUC 0-∞) for LY2801653 and Major Metabolites LSN2800870 and LSN2887652 |  | Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3 |