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A Multiple Dose Study of LY3023703 in Healthy Participants

NCT ID: NCT01849055

Last Updated: 2018-12-14

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

2013-05-31

Study Completion Date

2013-12-31

Brief Summary

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This is a study of LY3023703 in healthy participants. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream and how long it takes the body to remove the study drug. The effects of LY3023703 on blood pressure after 28 days of dosing will be studied. Information about any side effects that occur will be collected. The study is expected to last 21 weeks.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Placebo matching LY3023703 administered orally, once daily (QD), for 28 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

LY3023703

Escalating doses (2.5 milligram \[mg\] up to 30 mg) of LY3023703 administered orally, QD, for 28 days

Group Type EXPERIMENTAL

LY3023703

Intervention Type DRUG

Administered orally

Celecoxib

400 mg celecoxib administered orally, QD, for 28 days. (Positive control.)

Group Type ACTIVE_COMPARATOR

Celecoxib

Intervention Type DRUG

Administered orally

Interventions

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Placebo

Administered orally

Intervention Type DRUG

LY3023703

Administered orally

Intervention Type DRUG

Celecoxib

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Overtly healthy individuals based on the history and physical examinations as determined by the investigator
* Are normotensive (defined as supine systolic blood pressure \[BP\] less than 140 millimeters of mercury \[mm Hg\] and diastolic BP less than 90 mm Hg without the use of any antihypertensives) or results that are judged to be not clinically significant by the investigator

Exclusion Criteria

* Have presence of clinically significant active bleeding or history of bleeding diathesis at the time of screening
* Have presence of active peptic ulcer disease, gastro-intestinal (GI) bleeding, chronic gastritis, inflammatory bowel disease, or chronic diarrhea
* Have evidence of other chronic liver disease
* Have any use of nonsteroidal anti-inflammatory drugs (NSAIDs), celecoxib, aspirin, or acetaminophen (at doses greater than 1 gram per day \[g/day\] within 14 days of admission
* Have greater than 1 plus pretibial pitting edema or 2 plus ankle or pedal edema
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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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.

Evansville, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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I6H-MC-MCBB

Identifier Type: OTHER

Identifier Source: secondary_id

14708

Identifier Type: -

Identifier Source: org_study_id