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A Study of LY3023414 Formulations and the Effect of Food

NCT ID: NCT02818335

Last Updated: 2016-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-10-31

Brief Summary

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The purpose of this study is to measure how much LY3023414 (a test formulation and a reference formulation) gets into the blood stream and how long it takes the body to get rid of it.

The study will also evaluate the effects of a high fat meal on LY3023414 compared to taking LY3023414 on an empty stomach. In addition, the tolerability of the study drug formulations will be evaluated. Information about any side effects that may occur will be collected.

This study includes 3 periods. Participants will be admitted to the clinical research unit (CRU) one day before dosing in each period. Total study duration is about 21 days, including follow-up. Screening may occur up to 30 days before the first dose of study drug.

This study is for research purposes only and is not intended to treat any medical conditions.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3023414 Reference Fasted

Single oral dose of LY3023414 (Reference) on day one fasting.

Group Type EXPERIMENTAL

LY3023414 Reference Fasted

Intervention Type DRUG

Administered Orally

LY3023414 Test Fasted

Single oral dose of LY3023414 (Test) on day one fasting.

Group Type EXPERIMENTAL

LY3023414 Test Fasted

Intervention Type DRUG

Administered Orally

LY3023414 Test Fed

Single oral dose of LY3023414 (Test) on day one after a meal.

Group Type EXPERIMENTAL

LY3023414 Test Fed

Intervention Type DRUG

Administered Orally

Interventions

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LY3023414 Reference Fasted

Administered Orally

Intervention Type DRUG

LY3023414 Test Fasted

Administered Orally

Intervention Type DRUG

LY3023414 Test Fed

Administered Orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy surgically sterile or postmenopausal females and sterile males
* Have a body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²), inclusive at screening

Exclusion Criteria

* Cannot be investigative site personnel directly affiliated with this study or their immediate families. Immediate family is defined as a spouse, biological or legal guardian, child, or sibling
* Cannot be Lilly employees
* Have known allergies to LY3023414, related compounds, or any components of the formulation
* Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Show evidence of hepatitis C and/or positive hepatitis C antibody
* Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Minimum Eligible Age

18 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 Clinical Research Inc

Daytona Beach, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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I6A-EW-CBBB

Identifier Type: OTHER

Identifier Source: secondary_id

15696

Identifier Type: -

Identifier Source: org_study_id