EUCTR2008-004152-71-GB进行中（未招募）不适用
A Phase 2, Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Assess the Safety and Efficacy of TWO Weeks of Oral Senicapoc Administration on Allergen challenge in Atopic Asthmatic Subjects.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Icagen, Inc.
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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