A Single Dose Study of LY3023703 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: LY3023703; Drug: Celecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01632579

I6H-MC-MCBA (Other Identifier)

14707

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

LY3023703

Experimental group

Description:

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.

Treatment:

Drug: LY3023703

400 mg Celecoxib

Active Comparator group

Description:

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

Treatment:

Drug: Celecoxib