A Study of Evacetrapib and Digoxin in Healthy Participants

NCT ID: NCT01897493

Last Updated: 2018-10-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-09-30

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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Digoxin

0.5 milligram (mg) digoxin administered orally once daily (QD) on Day 1

Group Type ACTIVE_COMPARATOR

Digoxin

Intervention Type DRUG

Administered orally

Evacetrapib + Digoxin

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

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Administered orally

Digoxin

Intervention Type DRUG

Administered orally

Interventions

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Evacetrapib

Administered orally

Intervention Type DRUG

Digoxin

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY2484595

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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I1V-MC-EIAQ

Identifier Type: OTHER

Identifier Source: secondary_id

14619

Identifier Type: -

Identifier Source: org_study_id

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