Sulindac Capsules Compared With Sulindac Tablets in Healthy Volunteers

Mayo Clinic

Status: Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Drug: sulindac; Other: pharmacological study

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00343629

MAYO-03-1-BIO

MAYO-05-004233

CDR0000473167

MAYO-CPN0576

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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])