A Study of LY3079514 in Healthy Participants

NCT ID: NCT02242903

Last Updated: 2018-10-04

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-06-30

Brief Summary

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The main purpose of this study is to evaluate the safety and how well the body will handle a single dose of study drug, LY3079514. This study will last about 12 weeks for each participant.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3079514

Single dose of LY3079514 administered intravenous (IV) or subcutaneous (SC) during a single occasion

Group Type EXPERIMENTAL

LY3079514

Intervention Type DRUG

Administered SC

LY3079514

Intervention Type DRUG

Administered IV

Placebo

Single dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Placebo

Intervention Type DRUG

Administered IV

Interventions

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LY3079514

Administered SC

Intervention Type DRUG

LY3079514

Administered IV

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Placebo

Administered IV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Overtly healthy participants as determined by medical history and physical examination
* To qualify as Japanese for the purpose of this study, the Japanese participant must be first-generation Japanese
* Have a body mass index (BMI) between 18.5 and 32.0 kilograms per square meter (kg/m\^2) and have a minimum body weight of 50 kilograms (kg), inclusive at screening
* Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

Exclusion Criteria

* Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have an abnormal blood pressure that is considered to be clinically significant, as determined by the investigator
* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
* Have known or ongoing psychiatric disorders
* 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

Maximum Eligible Age

60 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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California Clinical Trials Medical Group

Glendale, California, United States

Site Status

Countries

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United States

Other Identifiers

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I7B-MC-DPAA

Identifier Type: OTHER

Identifier Source: secondary_id

15190

Identifier Type: -

Identifier Source: org_study_id

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