Safety and Efficacy Study of Oral Senicapoc on Allergen Challenge in Atopic Asthmatic Subjects

Exclusion Criteria

• •Any subject who has experienced any allergic reaction to a drug that suggests an increased potential for a hypersensitivity to senicapoc (e.g. clotrimazole);
• •Previous ingestion of senicapoc (ICA-17043) prior to Screening Visit 1;
• •Any condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs;
• •Respiratory tract infection or asthma exacerbation within 4 weeks of the first Screening Visit or within the period between Screening Visit 1 and Day 1 unless study physician believes lung function was unaffected (no greater than 10% decrease in baseline FEV1) by such event;
• •Considering or scheduled to undergo any surgical procedure during the duration of the study;
• •History of alcohol and/or drug abuse within 2 years prior to Screening Visit 1;
• •Donation of blood (\>450 mL) or significant loss of blood within 56 days prior to Screening Visit 1;
• •Received any commercially licensed investigational product within 30 days prior to Screening Visit 1 or received any unlicensed investigational product within 90 days prior to Screening Visit 1;
• •History of chronic hepatitis B or C, a positive test for hepatitis B surface antigen, hepatitis C antibody, a history of HIV infection, or demonstration of HIV antibodies;
• •A positive qualitative urine drug test, a positive urine or breath alcohol test, or a positive urine cotinine or CO breath test at the first Screening visit or on Day 1;
• •Use of oral or inhaled or intranasal corticosteroid, long acting beta agonists (e.g., salmeterol or formoterol), leukotriene receptor antagonists (e.g., zafirlukast or montelukast), theophylline, nedocromil sodium, cromolyn sodium, zileuton , or anti-cholinergic agents within the 28 days prior to the first Screening visit;
• •Use of oral antihistamines within 1 week prior to the first Screening visit;
• •Symptomatic with hay fever during any of the Screening Visits or Day 1;
• •A \>10 pack year cigarette history.