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A Single Dose Study of LY3023703 in Healthy Participants

Information source: Eli Lilly and Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: LY3023703 (Drug); Placebo (Drug); Celecoxib (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company


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.

Clinical Details

Official title: A Single-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3023703 in Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome: Number of participants with one or more drug related adverse events (AEs) or any serious AEs

Secondary outcome:

Pharmacokinetics: maximum concentration (Cmax) of LY3023703

Pharmacokinetics: area under the concentration curve (AUC) of LY3023703

Pharmacodynamics: percent change from baseline of ex vivo whole blood prostaglandin E (PGE) synthesis after lipopolysaccharide (LPS) stimulation

Pharmacodynamics: percent change from baseline of urinary excretion of prostaglandin E(2) metabolite (PGEM)

Pharmacodynamics: percent change from baseline of urinary excretion of prostacyclin metabolite (PGIM)

Pharmacodynamics: percent change from baseline of urinary excretion of thromboxane A metabolite (TXAM)


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


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

Locations and Contacts

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
Additional Information

Starting date: June 2012
Last updated: September 28, 2012

Page last updated: August 23, 2015

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