A Study to Evaluate the Effect of Increased Stomach pH on Evacetrapib in Healthy Participants

NCT ID: NCT02365558

Last Updated: 2018-10-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-04-30

Brief Summary

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The purpose of this study is to evaluate the effect of increased stomach pH on how much evacetrapib is found in the blood stream and how long the body takes to get rid of it when given to healthy participants. Information about any side effects that may occur will also be collected.

There are two parts to the study. Participation in both parts will be required.

The study will last approximately 30 days, not including screening.

Detailed Description

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Conditions

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Healthy

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

Single oral dose of evacetrapib administered alone on Day 1 of Period 1.

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Administered orally

Omeprazole + Evacetrapib

In Period 2, participants will receive 40 mg oral dose of Omeprazole once daily (QD) on Days 8 through 20.

Evacetrapib will be co-administered once, orally on Day 14.

Group Type EXPERIMENTAL

Evacetrapib

Intervention Type DRUG

Administered orally

Omeprazole

Intervention Type DRUG

Administered orally

Interventions

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Evacetrapib

Administered orally

Intervention Type DRUG

Omeprazole

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
* Females must be of non-child-bearing potential
* Have a body mass index of 18 to 32 kilograms per square meter (kg/m\^2)

Exclusion Criteria

* Have known allergies to evacetrapib, omeprazole, related compounds, or any components of the evacetrapib or omeprazole formulations
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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Covance Madison

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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I1V-MC-EIBO

Identifier Type: OTHER

Identifier Source: secondary_id

15373

Identifier Type: -

Identifier Source: org_study_id

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