A Study of Evacetrapib in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to determine whether concentrations of the study drug (evacetrapib) in the blood stream is the same or is different when the person is also taking gemfibrozil (a drug used to lower lipid levels). Each participant will receive gemfibrozil alone, evacetrapib alone, and both drugs in combination. There is no washout period between doses. The safety of both of the study drugs given together will be evaluated. Information about any side effects that may have occurred will also be collected. This study will last approximately 36 days.

Official Title
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Effect of Gemfibrozil on the Pharmacokinetics of Evacetrapib (LY2484595) in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Evacetrapib
* Drug: Gemfibrozil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy participants as determined by medical history and physical examination Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2) Exclusion Criteria: Have known allergies to evacetrapib and gemfibrozil, related compounds or any components of the formulation 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 Regularly use known drugs of abuse and/or show positive findings on urinary drug screening Currently smoke cigarettes or use tobacco or nicotine substitutes

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: Gemfibrozil<br>Single oral dose of 600 milligrams (mg) gemfibrozil on Day 1 | Drug: Gemfibrozil<br> <br> |
| Experimental: Evacetrapib<br>Oral doses of 130 mg evacetrapib once a day (QD) for 10 days (Day 2 through Day 12) | Drug: Evacetrapib<br> <br> * Other names: LY2484595;|
| Experimental: Evacetrapib + Gemfibrozil<br>Oral doses of 600 mg gemfibrozil twice a day (BID) and 130 mg evacetrapib QD for 10 days (Day 13 through Day 22). Single oral dose of 600 mg gemfibrozil on Day 23. | Drug: Evacetrapib<br> <br> * Other names: LY2484595;Drug: Gemfibrozil<br> <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 Evacetrapib | Venous blood samples were taken on Day 11 for PK parameter estimates of evacetrapib alone and on Day 22 for PK parameter estimates of evacetrapib when coadministered with gemfibrozil. | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Day 11 and Day 22 | 
| Pharmacokinetics (PK): Area Under the Concentration Curve Over a 24 Hour Dosing Interval (AUCτ) of Evacetrapib | Venous blood samples were taken on Day 11 for PK parameter estimates of evacetrapib alone and on Day 22 for PK parameter estimates of evacetrapib when coadministered with gemfibrozil. | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Day 11 and Day 22 | 
| Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib | Venous blood samples were taken on Day 11 for PK parameter estimates of evacetrapib alone and on Day 22 for PK parameter estimates of evacetrapib when coadministered with gemfibrozil. | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose on Day 11 and Day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Curve Over a 12 Hour Dosing Interval (AUCτ) of Gemfibrozil | Venous blood samples were taken on Day 1 for PK parameter estimates of gemfibrozil alone and on Day 13 for PK parameter estimates of gemfibrozil when coadministered with evacetrapib. | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Day 1 and Day 13 | 
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Gemfibrozil | Venous blood samples were taken on Day 1 for PK parameter estimates of gemfibrozil alone and on Day 13 for PK parameter estimates of gemfibrozil when coadministered with evacetrapib. | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Day 1 and Day 13 | 
| Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Gemfibrozil | Venous blood samples were taken on Day 1 for PK parameter estimates of gemfibrozil alone and on Day 13 for PK parameter estimates of gemfibrozil when coadministered with evacetrapib. | Predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose on Day 1 and Day 13 |