Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers

Bioequivalency Study of Sulindac in Capsule vs. Tablet Formulations

RATIONALE: Giving healthy volunteers sulindac capsules or sulindac tablets may help doctors learn which form of the drug may be more effective in preventing cancer.

PURPOSE: This randomized clinical trial is studying sulindac capsules to see how well they work compared with sulindac tablets in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Intervention / Treatment: Other: pharmacological study; Drug: sulindac

Detailed Description

OBJECTIVES:

Primary

• Compare the systemic exposure of sulindac tablets vs sulindac capsules in healthy volunteers.

Secondary

• Compare the terminal half-life and time of peak drug concentration of sulindac tablets vs sulindac capsules.

OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 treatment arms.

• Arm I: Participants receive one sulindac capsule followed 7-10 days later by one sulindac tablet.
• Arm II: Participants receive one sulindac tablet followed 7-10 days later by one sulindac capsule.

Blood is collected periodically during treatment for pharmacokinetic studies.

After completion of study therapy, participants are followed at 7-10 days.

PROJECTED ACCRUAL: A total of 28 participants will be accrued for this study.

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• Healthy volunteer

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Hemoglobin ≥ 12.0 g/dL (women)
• Hemoglobin ≥ 13.5 g/dL (men)
• WBC > 3,000/mm³
• Platelet count > 100,000/mm³
• Absolute neutrophil count > 1,500/mm³
• Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• ALT ≤ 1.5 times ULN
• Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 30 mL/min
• No history of allergic reactions or hypersensitivity to sulindac or other NSAIDs, including aspirin-sensitive asthma or urticaria
• No condition that interferes with ingestion or absorption of oral medications
• No cancer within the past 3 years except nonmelanomatous skin cancer, localized prostate cancer, carcinoma in situ of the cervix, or superficial bladder cancer that was previously treated > 6 months ago

• No uncontrolled concurrent illness including, but not limited to, the following:

  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Myocardial infarction in the past 6 months
  • Chronic renal disease
  • Chronic liver disease
  • Hypertension that is difficult to control
  • Psychiatric illness or social situations that would limit study compliance
• No other significant clinical disorder or laboratory finding that would preclude study participation
• No consumption of alcoholic or caffeinated beverages for ≥ 24 hours prior to study drug administration and until all blood samples have been drawn
• Willing to provide required biologic specimens

PRIOR CONCURRENT THERAPY:

• More than 6 months since prior investigational agents

• More than 6 months since prior regular use of (defined as a frequency of 7 consecutive days for > 3 weeks or > 21 days total) or other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase (COX)-2 inhibitors including, but not limited to, the following:

  • Ibuprofen
  • Ketoprofen
  • Naproxen
• More than 6 weeks since prior oral corticosteroids

• More than 30 days since prior and no concurrent use of any of the following:

  • Methotrexate
  • Corticosteroids
  • Warfarin
  • Ticlopidine
  • Clopidogrel
  • Low molecular weight heparins
  • Abciximab
  • Dipyridamole
  • Eptifibatide
  • Tirofiban
  • Lithium
  • Cyclosporine
  • Hydralazine

  • Angiotensin-converting enzymes (ACE) inhibitors

    • ACE-receptor antagonists allowed
  • Angiotensin-receptor blockers
  • Ginkgo
  • Ketorolac
  • Levofloxacin
  • Loop diuretics
  • Meadowsweet
  • Selective serotonin reuptake inhibitors
  • Danaparoid

• No concurrent regular aspirin use unless prescribed by a physician for prevention

  • A maximum of one aspirin (81 mg/day) allowed
• No concurrent herbal products (e.g., saw palmetto or Hypericum perforatum [St. John's wort])

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Paul J. Limburg, MD, MPH, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: June 22, 2006
• First Submitted That Met QC Criteria: June 22, 2006
• First Posted (Estimate): June 23, 2006

Study Record Updates

• Last Update Posted (Estimate): April 28, 2015
• Last Update Submitted That Met QC Criteria: April 27, 2015
• Last Verified: December 1, 2006

More Information

Terms related to this study

• Keywords: unspecified adult solid tumor, protocol specific
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Sulindac
• Other Study ID Numbers: CDR0000473167; MAYO-03-1-BIO; MAYO-CPN0576; MAYO-05-004233