Zileuton With or Without Celecoxib As Chemopreventive Agents in Smokers

Exclusion Criteria

• •The participant has active cancer (excluding non-melanoma skin cancer)
• •The participant has a history of curatively treated cancer with surgical therapy finished within 6 months prior to the Screening visit; or has had chemotherapy, cancer-related immunotherapy, hormonal therapy (other than Hormone replacement therapy (HRT) for menopause), or radiation therapy within 12 months of the screening visit
• •The participant has a chronic inflammatory condition, including but not limited to, ulcerative colitis, Crohn's disease, rheumatoid arthritis, psoriasis, gout and pancreatitis
• •The participant has an ongoing or active infection, including but not limited to HIV, pneumonia, urinary tract infection
• •The participant has a history of nonsteroidal anti-inflammatory drugs (NSAIDs) use, including aspirin (low-dose aspirin also prohibited) and selective COX-2 inhibitors within the previous 4 weeks
• •The participant has used zileuton or a leukotriene receptor antagonist within the previous 4 weeks
• •The participant has a history of corticosteroid use (excluding topical nasal sprays and dermal application) within the last 6 weeks
• •The participant has an acute or chronic kidney disorder
• •The participant exhibits clinical evidence of active liver disease or history of chronic liver disease
• •The participant has active cardiac disease, or a history of myocardial infarction, angina or coronary artery disease within the past 6 months
• •The participant has a history of a cerebrovascular accident (CVA) or transient ischemic attack (TIA)
• •The participant has a bleeding history
• •The participant is taking drugs known to interact with zileuton or celecoxib, including theophylline, warfarin, propranolol, fluconazole or lithium
• •The participant has received any investigational medication within 30 days of the screening visit or is scheduled to receive an investigational agent during the study
• •The participant is pregnant or nursing; women must not be pregnant or lactating
• •The participant is a female of child-bearing potential (women are considered not of childbearing potential if they are at least two years postmenopausal and/or surgically sterile) who has not used adequate contraception (abstinence; barrier methods such as intrauterine device (IUD), diaphragm with spermicidal gel, condom, or others; and hormonal methods such as birth control pills or others) since her last menses prior to study entry
• •The participant is a female of child-bearing potential or male who does not agree to use adequate contraception for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
• •The participant has participated in the study previously and was withdrawn
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• •Pregnant or nursing participants or those who are HIV-positive will be excluded from the study