A Study of Evacetrapib in Japanese and Non-Japanese Participants

NCT ID: NCT01958489

Last Updated: 2018-10-09

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-01-31

Brief Summary

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The main purpose of this study is to look at the effect of evacetrapib on pravastatin levels in the blood when both drugs are taken at the same time. The study will also assess how well the body handles evacetrapib and pravastatin when given at the same time.

This study has two periods in fixed order. Each participant will enroll in both periods. This study will last approximately 25 days, 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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Pravastatin

Single 40 milligram (mg) oral dose of pravastatin administered on Day 1.

Group Type EXPERIMENTAL

Pravastatin

Intervention Type DRUG

Administered orally

Evacetrapib + Pravastatin

Oral doses of 130 mg evacetrapib administered once daily on Days 2 through 11, with a single oral dose of 40 mg pravastatin coadministered on Day 11.

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Administered orally

Pravastatin

Intervention Type DRUG

Administered orally

Interventions

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Evacetrapib

Administered orally

Intervention Type DRUG

Pravastatin

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY2484595

Eligibility Criteria

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Inclusion Criteria

* Overtly healthy participants, as determined by medical history and physical examination
* Have a body mass index of 18 to 32 kilograms per square meter (kg/m²)
* Japanese participants must be first generation Japanese
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.

Leeds, West Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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I1V-MC-EIAW

Identifier Type: OTHER

Identifier Source: secondary_id

14625

Identifier Type: -

Identifier Source: org_study_id

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