Variability in Response to Non-steroidal Anti-inflammatory Drugs
Condition: Healthy
Intervention: Celecoxib; Naproxen; Placebo
Intervention MeSH terms: Celecoxib; Naproxen
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Non-steroidal Anti-inflammatory Drugs; Healthy volunteers; Celecoxib; Naproxen; Prostaglandin; Cyclooxygenase

Summary:

      This research study will evaluate inter-individual variability in the response to the
      non-steroidal anti-inflammatory drugs (NSAIDs), celecoxib and naproxen, among healthy adults.
      It will also investigate what factors, like age, sex, or genetic background, cause this
      variability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult men and women greater than 18 years of age who are non-smokers and in good
             health based on medical history, physical examination, vital signs, and laboratory
             tests. Volunteers with adequately controlled hypertension and hyperlipidemia (total
             cholesterol of ≤270 mg/dL) may participate in the study.

        Exclusion Criteria:

          -  Female subjects who are pregnant or nursing a child.

          -  Subjects who have received an investigational drug or used an experimental medical
             device within 30 days prior to screening, or who gave a blood donation of ≥ one pint
             within 8 weeks prior to screening.

          -  Subjects with any coagulation, bleeding or blood disorders.

          -  Subjects who are sensitive or allergic to celecoxib (Celebrex) or naproxen (Naprosyn)
             or their components.

          -  Subjects who are sensitive or allergic to aspirin or other NSAIDs.

          -  Subjects with documented history of any gastrointestinal disorders, including bleeding
             ulcers.

          -  History of significant cardiovascular disease (including stroke or TIA), renal,
             hepatic, respiratory (except infections which longer > 6 months prior to screening),
             immune, endocrine, hematopoietic disorder or neurological disorders.

          -  History of cancer within the last 5 years (except for cutaneous basal cell or squamous
             cell cancer resolved by excision, or carcinoma in situ of the cervix adequately
             treated).

          -  Has taken any prescription medication other than hormone replacement therapy
             (including males taking testosterone as a hormone replacement to treat a documented
             low testosterone level), thyroid replacement hormones, anti-hyperlipidemic agents, or
             anti-hypertensive medications. Individuals taking other/additional chronic stable
             medications can be considered on a case-by-case basis for inclusion in the study if
             agreed upon by judgment of the investigators.

          -  Has taken NSAIDs or anti-secretory agents (proton pump inhibitors or H2 receptor
             antagonists) within 14 days prior to study drug administration

          -  Has ever taken the any anti-platelet or anti-coagulant agents

          -  Used dietary or herbal supplements containing salicylates, Vitamin E, fish oil, or any
             other herbal supplements, within 14 days of study drug administration.

          -  Subjects with any abnormal laboratory value or physical finding that according to the
             investigator may interfere with interpretation of the study results, be indicative of
             an underlying disease state, or compromise the safety of a potential subject.

          -  Subjects who have had a history of drug or alcohol abuse within the last 6 months.

          -  Subjects who are unwilling to provide a blood sample for genetic analyses and creation
             of a lymphoblastoid cell line.