A Study of Evacetrapib and Rifampin in Healthy Participants

NCT ID: NCT01908582

Last Updated: 2018-10-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 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 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.

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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Evacetrapib

Period 1:

130 milligram (mg) evacetrapib administered orally, once on Day 1

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Administered orally

Evacetrapib + Rifampin

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

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Administered orally

Rifampin

Intervention Type DRUG

Administered orally

Interventions

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Evacetrapib

Administered orally

Intervention Type DRUG

Rifampin

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 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
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.

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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I1V-MC-EIAZ

Identifier Type: OTHER

Identifier Source: secondary_id

14636

Identifier Type: -

Identifier Source: org_study_id

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