A Single Dose Study of LY3023703 in Healthy Participants - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy Volunteers	Drug: LY3023703 Drug: Placebo Drug: Celecoxib	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Official Title:	A Single-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of LY3023703 in Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Number of participants with one or more drug related adverse events (AEs) or any serious AEs [ Time Frame: Baseline up to 7 days after administration of study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics: maximum concentration (Cmax) of LY3023703 [ Time Frame: Baseline up to 7 days after administration of study drug ] [ Designated as safety issue: No ]
Pharmacokinetics: area under the concentration curve (AUC) of LY3023703 [ Time Frame: Baseline up to 7 days after administration of study drug ] [ Designated as safety issue: No ]
Pharmacodynamics: percent change from baseline of ex vivo whole blood prostaglandin E (PGE) synthesis after lipopolysaccharide (LPS) stimulation [ Time Frame: Baseline up to 7 days post dose ] [ Designated as safety issue: No ]
Pharmacodynamics: percent change from baseline of urinary excretion of prostaglandin E(2) metabolite (PGEM) [ Time Frame: Baseline up to 24 hours post dose ] [ Designated as safety issue: No ]
Pharmacodynamics: percent change from baseline of urinary excretion of prostacyclin metabolite (PGIM) [ Time Frame: Baseline up to 12 hours post dose ] [ Designated as safety issue: No ]
Pharmacodynamics: percent change from baseline of urinary excretion of thromboxane A metabolite (TXAM) [ Time Frame: Baseline up to 12 hours post dose ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	June 2012
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Single dose of placebo administered orally on up to one occasion separated by at least a 3 week wash out period.	Drug: Placebo Administered orally
Experimental: LY3023703 Up to 6 single escalating doses of LY3023703 (0.1 mg up to 60 mg) administered orally on up to two occasions per participant separated by at least a 3 week wash out period.	Drug: LY3023703 Administered orally
Active Comparator: 400 mg Celecoxib Positive control. Single 400 mg dose of celecoxib administered orally, open label, on one occasion separated by at least a 3 week washout period.	Drug: Celecoxib Administered orally

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632579

Locations

United States, Indiana
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

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT01632579 History of Changes
Other Study ID Numbers:	14707, I6H-MC-MCBA
Study First Received:	June 25, 2012
Last Updated:	September 28, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 21, 2013