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A Study of LY2157299 in Healthy Participants

NCT ID: NCT01965808

Last Updated: 2013-12-04

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

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2013-12-31

Brief Summary

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Participants in this study will receive two oral doses of 150 milligram (mg) LY2157299 taken at least 4 days apart. One dose will be given without food. One dose will be given with a high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug gets into the blood stream. Side effects will be documented. This study will last approximately 15 days not including screening. Screening is required within 30 days prior to the start of the study.

Detailed Description

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Conditions

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Healthy Volunteers

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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LY2157299 (Fasted)

Single dose of 150 mg LY2157299 administered orally in fasted state in one of two study periods.

Group Type EXPERIMENTAL

LY2157299

Intervention Type DRUG

Administered orally

LY2157299 (Fed)

Single dose of 150 mg LY2157299 administered orally in fed state in one of two study periods.

Group Type EXPERIMENTAL

LY2157299

Intervention Type DRUG

Administered orally

Interventions

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LY2157299

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy sterile males or females
* Are able to eat a high fat meal
* No abnormal heart function or high blood pressure
* No participation in a clinical trial within 30 days
* No evidence of human deficiency virus (HIV), hepatitis C or hepatitis B

Exclusion Criteria

* Have a clinically significant abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Minimum Eligible Age

21 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.

Daytona Beach, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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H9H-MC-JBAU

Identifier Type: OTHER

Identifier Source: secondary_id

15239

Identifier Type: -

Identifier Source: org_study_id