A Single Dose Study of LY3023703 in Healthy Participants

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-09-30

Brief Summary

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This is a phase I 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 get rid of it when given to humans. Information about any side effects that may occur will also be collected. Participants will remain in the study for approximately 3 months. This study is for research purposes only and is not intended to treat any medical condition.

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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

DOUBLE

Participants Investigators

Study Groups

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Placebo

Single dose of placebo administered orally on up to one occasion separated by at least a 3 week wash out period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

LY3023703

Up to 6 single escalating doses of LY3023703 \[0.1 milligram (mg) up to 60 mg\] administered orally on up to two occasions per participant separated by at least a 3 week wash out period.

Group Type EXPERIMENTAL

LY3023703

Intervention Type DRUG

Administered orally

400 mg Celecoxib

Positive control. Single 400 mg dose of celecoxib administered orally, open label, on one occasion separated by at least a 3 week washout period.

Group Type ACTIVE_COMPARATOR

Celecoxib

Intervention Type DRUG

Administered orally

Interventions

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LY3023703

Administered orally

Intervention Type DRUG

Placebo

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
* Body mass index between 18.5 and 32.0 kilograms per square meter (kg/m\^2), inclusive

Exclusion Criteria

* Have known allergies to LY3023703 or any components of the formulation, celecoxib, or sulfonamides. Participants with known aspirin allergy, allergic reaction to nonsteroidal anti-inflammatory drugs (NSAIDs), or allergies or intolerance to other selective microsomal prostaglandin E synthase (mPGES-1) inhibitors should also be excluded
* Have the presence of active peptic ulcer disease, gastrointestinal (GI) bleeding, chronic gastritis, inflammatory bowel disease, or chronic diarrhea, or positive Helicobacter pylori serology
* Use NSAIDs, celecoxib, aspirin, or acetaminophen (at doses greater than 1 gram per day) within 14 days of screening

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes