A Study of Evacetrapib and Rifampin in Healthy Participants

Study Overview
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Brief Summary
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The main purpose of this study is to determine how much evacetrapib gets into the blood stream and how long it takes the body to get rid of it when given with rifampin. The safety and tolerability of the two drugs, given together, will also be evaluated. The study will also look at blood cholesterol levels and levels of a hormone called cortisol before and after taking rifampin. Information about any side effects that may occur will also be collected. For each participant, this study will include 2 periods in fixed order. The study will last approximately 29 days.

Official Title
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Effect of Rifampin on the Pharmacokinetics of Evacetrapib in Healthy Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Evacetrapib
* Drug: Rifampin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overtly healthy males and females (of non child-bearing potential) Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2), inclusive, at screening Exclusion Criteria: Have known allergies to evacetrapib, rifampin, related compounds or any components of either formulation, or history of significant allergic disease as determined by the investigator

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: Evacetrapib<br>Period 1: 130 milligram (mg) evacetrapib administered orally, once on Day 1 | Drug: Evacetrapib<br>* Administered orally<br>* Other names: LY2484595;|
| Experimental: Evacetrapib + Rifampin<br>Period 2: Rifampin: 600 mg administered orally, once daily (QD) for 14 days (Days 9 to 22) Evacetrapib: 130 mg administered orally once on Day 16 | Drug: Evacetrapib<br>* Administered orally<br>* Other names: LY2484595;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 Evacetrapib |  | Day 1 and Day 16, predose of evacetrapib and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose | 
| Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib |  | Day 1 and Day 16, predose of evacetrapib and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose | 
| Pharmacokinetics, Area Under the Plasma Concentration-Time Curve From Time 0 Hour (h) to Infinity (AUC0-∞) of Evacetrapib |  | Day 1 and Day 16, predose of evacetrapib and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose |