A Study of Abemaciclib in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to measure how much abemaciclib gets into the blood stream and how long it takes the body to get rid of it when given as capsules versus a tablet(s). The effect of a high fat meal on the tablet formulation will also be evaluated. In addition, the tolerability of abemaciclib tablet and capsule formulations will be evaluated. Information about any side effects that may occur will also be collected. This study has 3 parts. Parts A and C will last about 44 days including follow-up. Part B will last about 60 days including follow-up. Screening may occur up to 28 days before the first dose of study drug. Participants are only allowed to enroll in one part. This study is for research purposes only and is not intended to treat any medical condition.

Official Title
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A Bioequivalence Study Comparing Abemaciclib Capsule and Tablet Formulations and Effect of Food on Abemaciclib Tablet Pharmacokinetics in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Abemaciclib Capsules (Reference Formulation)
* Drug: Abemaciclib Tablet (Test Formulation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy surgically sterile or postmenopausal females and sterile males Have a body mass index (BMI) 18 to 32 kilograms per square meter (kg/m²) Exclusion Criteria: Have known allergies to abemaciclib, related compounds, or any components of the formulation Regularly use known drugs of abuse and/or show positive findings on urinary drug screening Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies Show evidence of hepatitis C and/or positive hepatitis C antibody Show evidence of hepatitis B and/or positive hepatitis B surface antigen

Ages Eligible for Study
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Minimum Age: 18 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: Abemaciclib Part A<br>Reference formulation (R) = 3 x 50 mg abemaciclib capsules, Test formulation (T150) = 150 mg abemaciclib tablet administered orally on Day 1 in each of 2 periods. | Drug: Abemaciclib Capsules (Reference Formulation)<br>* Administered orally<br>* Other names: LY2835219;Drug: Abemaciclib Tablet (Test Formulation)<br>* Administered orally<br>* Other names: LY2835219;|
| Experimental: Abemaciclib Part B<br>R = 3 x 50 mg abemaciclib capsules, T150 = 150 mg abemaciclib tablet, Test Formulation 50 (T50) = 3 x 50 mg abemaciclib tablets administered orally on Day 1 in each of 3 periods. | Drug: Abemaciclib Capsules (Reference Formulation)<br>* Administered orally<br>* Other names: LY2835219;Drug: Abemaciclib Tablet (Test Formulation)<br>* Administered orally<br>* Other names: LY2835219;|
| Experimental: Abemaciclib Part C<br>T150 Fed and T150 Fasted = 150 mg abemaciclib tablet with a high-fat meal (T150 Fed) and then without a high-fat meal (T150 Fasted) on Day 1 in each of 2 periods administered orally. | Drug: Abemaciclib Tablet (Test Formulation)<br>* Administered orally<br>* Other names: LY2835219;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) | Area under the concentration versus time curve from zero to infinity. | Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose | 
| PK: Maximum Observed Drug Concentration (Cmax) | Maximum observed drug concentration. | Parts A and C Periods 1 and 2; Part B Periods 1, 2, 3: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 96, 120,144,168 and 192 hours postdose |