A Study of LY2835219 in Healthy Participants

Study Overview
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Brief Summary
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The aim of this 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 as an intravenous infusion (given directly into a vein via a small needle). The study will also provide information on how well the study drug is tolerated when given as a capsule in combination with giving it intravenously, and information on any changes in heart function. The study will last about 10 days. Screening is required within 28 days before study drug is given.

Official Title
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An Absolute Bioavailability Study of LY2835219 in Healthy Subjects Using the Intravenous Tracer Method

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: LY2835219
* Drug: ¹³C₈-LY2835219


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) Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site. Participants who are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures Exclusion Criteria: Have participated in a clinical trial involving investigational product within the last 90 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 consumed any sensitive CYP2B6 substrate drugs, any CYP3A4 inhibitor or any CYP3A inducer, herbal supplements, grapefruits or grapefruit containing products, Seville oranges or Seville orange containing products, star fruits or star fruit containing products within 2 weeks prior to dosing or intend to consume during the study Regularly use known drugs of abuse and/or show positive findings on urinary drug screening

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 200 mg LY2835219<br>200 mg LY2835219 administered orally on day 1. | Drug: LY2835219<br>* Administered orally<br>|
| Experimental: 0.4 mg ¹³C₈-LY2835219<br>0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose. | Drug: ¹³C₈-LY2835219<br>* Administered IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-∞)] of LY2835219 and ¹³C₈-LY2835219 |  | Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK: Maximum Observed Concentration (Cmax) of LY2835219 |  | Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose | 
| PK: Time of Maximum Observed Drug Concentration (Tmax) of LY2835219 |  | Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose |