A Study of LY2835219 in Healthy Participants

Study Overview
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Brief Summary
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Participants in this study will receive 3 single oral doses of LY2835219 at least 14 days apart. One dose will be given with a standard meal, one dose with a high-fat meal and one dose without food. The study will evaluate the effects of the standard and high-fat meals on how much drug gets into the bloodstream. Side effects will be documented. This study is approximately 43 days, not including screening. Screening is required within 28 days prior to the start of the study.

Official Title
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Effect of Food on the Pharmacokinetics of LY2835219 in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: LY2835219


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy sterile males or surgically sterile or postmenopausal females Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2), inclusive, at screening Are able to eat a high-fat, high-calorie meal Exclusion Criteria: Participated in a clinical trial involving investigational product within 30 days Abnormal blood pressure Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study Have donated blood of more than 500 milliliter (mL) within the last month Show evidence of human immunodeficiency virus, hepatitis B or hepatitis C

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY2835219 Standard<br>Single oral dose of LY2835219 given with a standard meal in one of three study periods. | Drug: LY2835219<br>* Administered orally.<br>* Other names: abemaciclib;|
| Experimental: LY2835219 Fasted<br>Single oral dose of LY2835219 given with no food in one of three periods. | Drug: LY2835219<br>* Administered orally.<br>* Other names: abemaciclib;|
| Experimental: LY2835219 High-Fat<br>Single oral dose of LY2835219 given with a high fat meal in one of three periods. | Drug: LY2835219<br>* Administered orally.<br>* Other names: abemaciclib;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat Arms |  | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period | 
| Pharmacokinetics: Area Under the Concentration Curve (0-t Last) [AUC(0-t Last)] of LY2835219 Fasted vs. High-Fat Arms |  | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period | 
| Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of LY2835219 Fasted vs. High-Fat Arms |  | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Cmax of LY2835219 in Standard Meal Arm |  | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period | 
| Pharmacokinetics: AUC(0-tlast) of LY2835219 in Standard Meal Arm |  | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period | 
| Pharmacokinetics: Tmax of LY2835219 in Standard Meal Arm |  | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period | 
| Pharmacokinetics: Area Under the Concentration Curve (AUC 0-t Last) of LSN3106726 (M20) | Area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of LSN3106726 (M20), an active metabolite of LY2835219. | Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period |