Asthma. MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: Senicapoc 10mg
Product Code: ICA-17043
Pharmaceutical Form: Tablet
CAS Number: 289656-45-7
Current Sponsor code: ICA 17043
Other descriptive name: Bis(4-fluorophenyl)phenyl acetamid
Sponsors
Icagen, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male, or female practicing acceptable contraceptive methods of 18 to 65; Having a history of asthma (as defined by the Global Initiative in Asthma definition or having been previously treated for asthma); Baseline (pre-bronchodilator) forced expiratory volume at one second (FEV1) =70% of predicted; Clinically acceptable medical history, physical examination, 12 lead ECG, vital signs, and clinical laboratory tests (based upon the Investigator’s overall evaluation); Positive response on screening to skin prick test to either house dust mite, cat hair, or grass pollen (within 12 months prior to Screening Visit 1); A positive inhaled methacholine challenge with a PC20 = 8 mg/mL (within 6 months prior to Screening Visit 1); Screening allergen challenge demonstrates that the subject experiences both an early and late asthmatic response. The early asthmatic response must include a fall in FEV1 of equal to or more than 20% from the post saline value, on at least one occasion, between 5 and 30 minutes after the final concentration of allergen. The late asthmatic response must include a fall in FEV1 of equal to or more than 15% from the post saline value, on at least three occasions, two of which must be consecutive, between 4 and 10 hours after the final concentration of allergen; Non-smoker (refrained from any tobacco usage or any products containing nicotine for 6 months prior to Screening Visit 1); Able and willing to give written informed consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any subject who has experienced any allergic reaction to a drug which, in the opinion of the investigator, 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, zilueton, 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and tolerability of multiple doses of senicapoc following oral administration to atopic asthma subjects; To characterize the effects of 14 days of senicapoc dosing on lung function response to allergen challenge and airway hyper-responsiveness to methacholine; To characterize the effects of 14 days of senicapoc dosing on changes in sputum inflammatory cell and cytokine profiles; and ;Secondary Objective: To characterize the senicapoc plasma concentrations in atopic asthma subjects. ;Primary end point(s): The primary endpoint will be a comparison of active vs. placebo in late asthmatic response to allergen challenge (LAR; 4 to 10 hours after allergen challenge). | — |
Countries
United Kingdom
Outcome results
None listed