Study to Assess Safety and Efficacy of Oral Senicapoc Administration on Exercise-induced Asthma

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether 4 weeks of dosing with senicapoc alleviates exercise induced asthma symptoms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icagen

Criteria

Inclusion Criteria:

• Able and willing to give written informed consent to participate in the study as HIPAA authorization;

• Clinically acceptable medical history, physical examination, 12 lead ECG, vital signs, and clinical laboratory tests

• History of physician-diagnosed asthma according to Global Initiative for Asthma, AND exercise-induced asthma/ bronchoconstriction;

• Current treatment for asthma with short-acting inhaled beta-2-agonist ONLY;

• Baseline FEV1 >65% of predicted at Screen Visit 1;

• A 20% or greater drop in FEV1 following exercise challenge on at least two separate occasions prior to enrollment;

• Non-smoker (refrained from any tobacco usage, or any products containing nicotine, for 6 months prior to Day 1);

Exclusion Criteria:

• Subject who has experienced any allergic reaction to a drug which, suggests an increased potential for a hypersensitivity to senicapoc (e.g., clotrimazole);

• Previous ingestion of senicapoc (ICA-17043)

• Pregnant or lactating female;

• Condition that might interfere with the absorption, distribution, metabolism, and/or excretion of drugs; subjects who have had any previous gastrointestinal surgery, except appendectomy or cholecystectomy (if performed more than 90 days prior to Screening Visit 1) or a history of clinically significant active cardiovascular, neurologic, endocrine, hepatic, or renal disorders;

• Infectious illness, e.g. acute bacterial, acute and chronic parasitic, fungal infection or viral infection within 6 weeks prior to Screening Visit 1 or between Screening Visit 1 and Day 1 (Randomization).

• Treatment for conditions other than asthma with systemic corticosteroids within 1 month prior to Visit 1.

• Asthma exacerbation having necessitated treatment with inhaled corticosteroids within 6 weeks prior to study Screening Visit 1.

• History of severe asthma as defined by use of oral/injectable corticosteroids within the last 3 months and/or more than two bursts in the last year.

• Undergoing desensitization therapy unless on a maintenance dose for at least 3 months prior to entry and will continue as such throughout study participation.

• History of chronic pulmonary diseases other than asthma.

• Considering or scheduled to undergo any surgical procedure during the duration of the study;

• Ingestion of any investigational medication within 30 days prior to Screening Visit 1;

• A positive plasma alcohol, or urine cotinine test at Screening Visit 1;

• Use of the following asthma medications for the stated period prior to Screening Visit 1 and throughout the study:

• Oral or parenteral corticosteroids within 3 months prior to Screening Visit 1

• Inhaled corticosteroids (ICS) (e.g., budesonide, fluticasone propionate) within 1 month prior to Screening Visit 1

• long acting beta agonists; leukotriene receptor antagonists; or anti-cholinergic agents (e.g. tiotropium) within the 2 weeks prior to Screening Visit;

• Use of antihistamines within 3 days prior to Screening Visit 1;

• Has a >10 pack-year history of smoking;

• Hypertension at screen (BP > 150/90), if deemed by Investigator to be unfit to complete exercise challenge testing;

• Screen QTc > 450 msec or ECG not suitable for QT measurement (e.g., poorly defined termination of T-wave);

• After exercise challenge test, subject not recovering to at least 90% of baseline FEV1 following administration of short-acting beta-2-agonist.