A Single Dose Study of LY3023703 in Healthy Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01632579
First received: June 25, 2012
Last updated: September 28, 2012
Last verified: September 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 15, 2014