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
Summary
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 LY3023703Pharmacokinetics: 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)
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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
|