NCT01704404已完成2 期
A Phase 2 Study of the Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Multiple Doses of TD-4208 for 7 Days in Subjects Diagnosed With Chronic Obstructive Pulmonary Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Change From Baseline to Day 7 in Trough FEV1 (Forced Expiratory Volume in 1 Second)
研究概览
简要总结
This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects with Chronic Obstructive Pulmonary Disease (COPD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is a male or female between the ages of 40 and 75 years (inclusive, at randomization).
- •Has an FEV1/FVC (forced expiratory volume in 1 second/forced vital capacity) <0.7 at screening; and
- •Has a post-bronchodilator FEV1 at screening of between 30% and 80% (inclusive) of the predicted normal value.
- •Subject demonstrates at screening at least a 120 mL increase in FEV1 within 1 hour of receiving 500 µg of ipratropium bromide from a PARI LC Sprint® nebulizer.
- •Females of non-childbearing potential. All male subjects must agree to use a highly effective method of birth control with partners of childbearing potential during the study and for 1 month after completion of study dosing.
- •Subject (or care giver) is able to properly prepare and administer study medication.
- •Subject is willing and able to give written informed consent to participate.
排除标准
- •Subject has had a COPD exacerbation or lung infection within 6 weeks before randomization.
- •Subject has had an initiation of treatment, or a change in dose, of an inhaled or oral corticosteroid, or long-acting beta2 agonist (LABA), or long-acting muscarinic antagonist (LAMA) within 4 weeks before the qualifying ipratropium bromide response test.
- •Subject is taking daily maintenance inhaled/systemic corticosteroids (>1000 μg of fluticasone propionate equivalent or ≥10 mg prednisone).
- •Subject has an uncontrolled hematologic, immunologic, renal, neurologic, hepatic, endocrine, or other disease or condition based on information gathered from the medical history, physical examination, or laboratory findings that might place the subject at undue risk or potentially compromise the results or interpretation of the study.
- •Subject has a history of significant cerebrovascular disease, coronary artery disease, or cardiac arrhythmias. Subject has a history (or family history) of congenital prolonged QTc (corrected QT interval) syndrome or has an abnormal clinically significant electrocardiogram (ECG) at screening, including QTcB (QT interval corrected for heart rate using Bazett's formula) value >450 msec (males) or >470 msec (females); or shows evidence of clinically significant rhythm abnormality.
- •Subject has a known hypersensitivity to TD-4208 or similar drug class.
- •Subject has a history of alcoholism or drug abuse within 2 years prior to screening.
研究组 & 干预措施
Dose 1 TD-4208
Experimental
22 µg
干预措施: TD-4208 (Drug)
Dose 2 TD-4208
Experimental
44 µg
干预措施: TD-4208 (Drug)
Dose 3 TD-4208
Experimental
88 µg
干预措施: TD-4208 (Drug)
Dose 4 TD-4208
Experimental
175 µg
干预措施: TD-4208 (Drug)
Dose 5 TD-4208
Experimental
350 µg
干预措施: TD-4208 (Drug)
Dose 6 TD-4208
Experimental
700 µg
干预措施: TD-4208 (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Day 7 in Trough FEV1 (Forced Expiratory Volume in 1 Second)
时间窗: From baseline to day 7
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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