Phase 1
N=30
A Single Dose Study of LY3023703 in Healthy Participants
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT01632579 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AE — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LY3023703 (Drug); Placebo (Drug); Celecoxib (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AE |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics: Maximum Concentration (Cmax) of LY3023703 |
1.15; 5.66; 23.5; 140; 547; 756 | — |
| SECONDARY Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3023703 |
3.19; 54.7; 245; 1680; 9940; 13800 | — |
| SECONDARY Pharmacodynamics: Percent Change From Baseline of ex Vivo Whole Blood Prostaglandin E (PGE) Synthesis After Lipopolysaccharide (LPS) Stimulation |
-10.1; 102.6; -11.6; 29.3; -12.1; -43.5 | — |
| SECONDARY Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostaglandin E(2) Metabolite (PGEM) |
4.2; 7.4; -4.0; 1.5; -5.3; 17.7 | — |
| SECONDARY Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Prostacyclin Metabolite (PGIM) |
-6.4; -34.6; 15.5; 22.4; -1.2; 33.1 | — |
| SECONDARY Pharmacodynamics: Percent Change From Baseline of Urinary Excretion of Thromboxane A Metabolite (TXAM) |
-9.1; -19.9; 6.5; -17.9; 8.7; 2.7 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01632579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.