A Study of LY2835219 in Healthy Participants

Study Overview
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Brief Summary
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The aim of this two-period study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and when it is given as a single oral dose in combination with rifampin (a Food and Drug Administration [FDA] approved antibiotic that is used to treat tuberculosis, a bacterial infection that mainly affects the lungs, and other infections). Each participant will complete both study periods. The study will last about 34 days. Screening is required within 28 days before study drug is given.

Official Title
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Effects of CYP3A Induction by Rifampin on the Pharmacokinetics of LY2835219 and Its Metabolites in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: LY2835219
* Drug: Rifampin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overtly healthy sterile males or surgically sterile females or postmenopausal females Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2) Exclusion Criteria: Have participated in a clinical trial involving investigational product within the last 30 days 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 an abnormal blood pressure Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C Have donated blood of more than 500 milliliters (mL) within the last month Have used or intend to use over-the-counter or prescription medication including herbal medications within 7 days prior to dosing or during the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY2835219<br>Single oral dose of LY2835219 | Drug: LY2835219<br>* Administered orally<br>* Other names: abemaciclib;|
| Experimental: LY2835219 + Rifampin<br>Single oral dose of LY2835219 with rifampin orally, once daily for 14 days | Drug: LY2835219<br>* Administered orally<br>* Other names: abemaciclib;Drug: Rifampin<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2835219 |  | Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours | 
| PK: Area Under the Concentration Time Curve AUC(0-∞) of LY2835219 |  | Period 1: Day 1- Predose,1, 2, 4, 6, 8, 10 hours, Days 2-9: 24, 48, 72, 96, 120, 144, 168, and 192 hours; Period 2: Day 7- Predose,1, 2, 4, 6, 8, 10 hours, Days 8-15: 24, 48, 72, 96, 120, 144, 168, 192 hours |