NCT01068145终止1 期
Randomized, Double-Blind, Multiple-Dose, Placebo-Controlled, Incomplete Crossover, Two-Part Study to Evaluate the Dose Response of SCH 527123 on Sputum Neutrophilia Following Ozone Challenge in Healthy Subjects and COPD Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 18
- 主要终点
- PD/PK: Dose response of SCH 527123 on ozone-induced sputum neutrophilia in healthy subjects (Part 1) and subjects with COPD (Part 2), measured by placebo-adjusted percent change in sputum neutrophil counts and absolute sputum neutrophil counts.
研究概览
简要总结
Trial to evaluate the dose response of SCH 527123 in reducing inflammation from an ozone-induced sputum neutrophilia in both healthy subjects and subjects with COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject of either sex and of any race between the age of 18 and 55 years, with a BMI (weight [kg]/height [m2]) between 19 and
- •Subject must have a FEV1 ≥ 80 % of predicted value.
- •Subject must be nonsmoker (including cigarettes, cigars and pipes) or exsmoker who has stopped smoking for at least 6 months (smoking history ≤ 5 pack years).
- •Subject's clinical laboratory tests (CBC, blood chemistry, urinalysis) must be within normal limits. Subjects must have a neutrophil count of >2.0 x 109/L. (also Part 2)
- •Subject must be free of any clinically significant disease that would interfere with the study evaluations (also Part 2).
- •Screening ECG conduction intervals must be within gender specific normal range; QTcB males ≤430 msec and females ≤450 msec (also Part 2).
- •Vital sign measurements must be: a) oral body temperature, between 35.0°C and 37.5°C; b) systolic blood pressure, 90 to 140 mm Hg (160 mm Hg, Part 2); c) diastolic blood pressure, 45 to 90 mm Hg (100 mm Hg, Part 2); d) pulse rate, 40 to 100 bpm.
- •Subject and partner(s) must be using an accepted method of contraception during the trial through 2 months post-treatment (also Part 2).
- •Prior to randomization, subject must be a responder to ozone (also Part 2).
- •Subject with a diagnosis of COPD for at least 1 year and FEV1 ≥65% of predicted value post bronchodilation (measurement 30 minutes after 400 mcg salbutamol administration) and FEV1/FVC of <70%.
- •Subject of either sex and of any race between the age of 40 and 65 years, with a BMI between 19 and
- •Subject must be active or exsmoker (cigarettes, cigars and/or pipes).
- •Subject must have a normal exercise stress test (no clinically significant ECG findings).
排除标准
- •Part 1 and Part 2
- •Female subject who is pregnant, intends to become pregnant (within 3 months of ending the study), or is breastfeeding.
- •Subject with history of seasonal or perennial allergic rhinitis (ie, season for specific allergen).
- •Subject who has an allergy or a contraindication to excipients in placebo or SCH 527123 formulations or salbutamol.
- •Surgical or medical condition (history or presence) which might alter the ADME of the drug: a) inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding; b) major gastrointestinal tract surgery, ie, gastrectomy, gastroenterostomy, or bowel resection; c) pancreatic injury or pancreatitis; d) liver disease or injury; e) impaired renal function indicated by abnormal creatinine, urinary albumin, BUN/urea or clinical significant urinary cellular constituents (eg, cast); or f) urinary obstruction or difficulty in voiding.
- •Subject who has any infectious disease within 4 weeks prior to drug administration.
- •Subject who is positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.
- •Subject who has a positive screen for drugs with a high potential for abuse (Screening and/or treatment period).
- •Subjects with a history of mental instability or who have been treated for mood disorder.
- •Subject with a history of alcohol or drug abuse in the past 2 years.
- •Subject who has donated blood in the past 60 days.
- •Subject who has demonstrated allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes) which may interfere with ability to participate in the trial.
- •Subject who has previously received SCH 527123 (Part 2 only)
- •Subject who has received any of the following treatments more recently than indicated washout period prior to Baseline:
- •Parts 1 and 2: OTC medications (excluding paracetamol), 14 days.
- •Part 1: prescription medications, 14 days; investigational drugs, 30 days.
- •Part 2: vitamins and herbal supplements, 14 days; statins, 4 weeks; steroids (inhaled), 4 weeks; steroids (oral and dermal), 8 weeks; antibiotics, 6 weeks; leukotriene antagonists, 4 weeks; NSAIDS, 2 weeks.
研究组 & 干预措施
Very low dose SCH 527123
Experimental
干预措施: SCH 527123 (Drug)
Low dose SCH 527123
Experimental
干预措施: SCH 527123 (Drug)
Medium dose SCH 527123
Experimental
干预措施: SCH 527123 (Drug)
High dose SCH 527123
Experimental
干预措施: SCH 527123 (Drug)
Placebo to match SCH 527123
Placebo Comparator
干预措施: Placebo (Drug)
Low dose SCH 527123 (Part 2)
Experimental
干预措施: SCH 527123 (Drug)
Medium dose SCH 527123 (Part 2)
Experimental
干预措施: SCH 527123 (Drug)
High dose SCH 527123 (Part 2)
Experimental
干预措施: SCH 527123 (Drug)
Placebo (Part 2)
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
PD/PK: Dose response of SCH 527123 on ozone-induced sputum neutrophilia in healthy subjects (Part 1) and subjects with COPD (Part 2), measured by placebo-adjusted percent change in sputum neutrophil counts and absolute sputum neutrophil counts.
时间窗: Part 1, four treatment periods, Part 2 three treatment periods duration of the trial.
次要结局
未报告次要终点
研究者
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