Variability in Response to Non-steroidal Anti-inflammatory Drugs

• Status: Active, not recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Celecoxib; Naproxen

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.