A Study of Evacetrapib and Digoxin 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 digoxin gets into the blood stream and how long it takes the body to get rid of it when given with the study drug evacetrapib. This study will also look at the effect of evacetrapib on the removal of digoxin from the body by the kidneys. Information about any side effects that may occur will be collected. This study will last approximately 33 days for each participant, not including screening.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Evacetrapib
* Drug: Digoxin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overtly healthy males and females (of non-childbearing potential) Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2) Normal renal function Exclusion Criteria: Participants who currently smoke or use tobacco or nicotine products

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 |
| --- | --- |
| Active Comparator: Digoxin<br>0.5 milligram (mg) digoxin administered orally once daily (QD) on Day 1 | Drug: Digoxin<br>* Administered orally<br>|
| Experimental: Evacetrapib + Digoxin<br>130 mg evacetrapib administered orally, QD for 14 days (Days 6 through 19) with a single oral dose of 0.5 mg digoxin coadministered on Day 15 | Drug: Evacetrapib<br>* Administered orally<br>* Other names: LY2484595;Drug: Digoxin<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 Observed Drug Concentration (Cmax) of Digoxin |  | Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin | 
| PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of Digoxin |  | Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin | 
| PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin |  | Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Clearance (CLr) of Digoxin | CLr was defined as the volume of serum cleared of digoxin per unit of time after a single dose of digoxin. | Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin |