A Study of LY3127760 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: Celecoxib; Drug: LY3127760

Study type: Interventional

Funder types: Industry

Identifiers

NCT01968070

I7A-MC-EACA (Other Identifier)

15181

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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80 participants in 5 patient groups, including a placebo group

LY3127760 (Single)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: LY3127760

Placebo (Single)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: LY3127760

LY3127760 (Multiple)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: LY3127760

Placebo (Multiple)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: LY3127760

Celecoxib (Multiple)

Active Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: LY3127760

Drug: Celecoxib