A Study of LY3127760 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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-04-30

Brief Summary

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The main purposes of this study are to evaluate the safety and how well the body handles single and multiple doses of increasing strength of study drug, LY3127760. This study includes three parts. Part 3 may be initiated at sponsor's discretion, based on data from Part 2. Participants will only enroll in 1 of the 3 study parts. This study will last approximately 7 to 13 weeks, depending on part. Screening must be completed within 28 days prior to enrollment.

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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

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3127760 (Single)

Single oral dose of up to 900 milligram (mg) LY3127760 administered in up to 3 of 3 study periods.

Group Type EXPERIMENTAL

LY3127760

Intervention Type DRUG

Administered orally

Placebo

Intervention Type DRUG

Administered orally

Placebo (Single)

Single oral dose of placebo administered in up to 2 of 3 study periods. Placebo matches LY3127760 in appearance.

Group Type PLACEBO_COMPARATOR

LY3127760

Intervention Type DRUG

Administered orally

Placebo

Intervention Type DRUG

Administered orally

LY3127760 (Multiple)

Multiple ascending oral doses of up to 900 mg LY3127760 administered once or twice daily (QD or BID) for 28 days.

Group Type EXPERIMENTAL

LY3127760

Intervention Type DRUG

Administered orally

Placebo

Intervention Type DRUG

Administered orally

Placebo (Multiple)

Multiple oral doses of placebo administered QD or BID for 28 days. Placebo matches LY3127760 in appearance.

Group Type PLACEBO_COMPARATOR

LY3127760

Intervention Type DRUG

Administered orally

Placebo

Intervention Type DRUG

Administered orally

Celecoxib (Multiple)

Multiple oral doses of 400 mg celecoxib administered QD for 28 days.

Group Type ACTIVE_COMPARATOR

LY3127760

Intervention Type DRUG

Administered orally

Celecoxib

Intervention Type DRUG

Administered orally

Placebo

Intervention Type DRUG

Administered orally

Interventions

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LY3127760

Administered orally

Intervention Type DRUG

Celecoxib

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Overtly healthy males or females as determined by medical history and physical examination
* Male participants agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product
* Female participants not of child-bearing potential
* Have a body mass index of 18.5 to 32 kilograms per square meter (kg/m\^2) inclusive
* 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 use of any antihypertensives

Exclusion Criteria

* Have known allergies to LY3127760, related compounds or any components of the formulation, celecoxib or sulfonamides, or history of significant atopy. Participants with known aspirin allergy or allergic reactions to nonsteroidal anti-inflammatory drugs (NSAIDs) should also be excluded
* Have any current or prior history of a significant gastrointestinal illness such as peptic ulcer disease, gastrointestinal (GI) bleeding, chronic gastritis, inflammatory bowel disease or chronic diarrhea
* Have evidence of other chronic liver disease, including but not limited to chronic alcoholic disease, nonalcoholic steatohepatitis, recent history (within 3 months of screening) of acute viral hepatitis or chronic autoimmune hepatitis
* Have used any NSAIDs, celecoxib, aspirin or acetaminophen (at doses greater than 1 gram per day), anticoagulants or antiplatelet agents within 14 days of admission

Part 2 and Part 3 only

* Have 1 plus pretrial pitting edema or 2 plus ankle or pedal edema

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes