NCT02820311已完成1 期
A Phase 1, Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Period Crossover Thorough QT Study to Evaluate the Effect of a Single Dose of TD-4208 on Cardiac Repolarization in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change-from-baseline in corrected QT
研究概览
简要总结
The purpose of this study is to evaluate if TD-4208, an investigational drug being developed to treat people with chronic obstructive pulmonary disease (COPD), has any effect on the electrical activity of the heart.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has a body mass index (BMI) of 19 to 32 kg/m2, inclusive, and weight of at least 55 kg.
- •Subject is able to communicate well with the investigator and to comply with the study procedures, requirements, and restrictions.
排除标准
- •Subject has a prior history of myocardial infarction, acute coronary syndrome, cerebrovascular accident, transient ischemic attack, ventricular tachycardia, atrial fibrillation, personal or known family history of congenital long QT syndrome or known family history of sudden death with unknown cause, a pacemaker or implantable cardioverter defibrillator, cardiac or cerebral stent placement or angioplasty, or clinically significant valvular heart disease.
- •Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematologic, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
研究组 & 干预措施
TD-4208 175 mcg
Experimental
double-blind
干预措施: TD-4208 175 mcg (Drug)
TD-4208 700 mcg
Experimental
double-blind
干预措施: TD-4208 700 mcg (Drug)
Placebo for TD-4208
Placebo Comparator
double-blind
干预措施: Placebo for TD-4208 (Drug)
Moxifloxacin 400 mg
Active Comparator
open-label
干预措施: Moxifloxacin 400 mg (Drug)
结局指标
主要结局
Change-from-baseline in corrected QT
时间窗: Predose to 24 hours postdose
次要结局
- Adverse Events(Predose to 24 hours postdose)
- Maximum Plasma Concentration Cmax(Predose to 24 hours postdose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary Disease (COPD)NCT02459080Mylan Inc.619
已完成
3 期
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)Chronic Obstructive Pulmonary Disease (COPD)NCT02512510Mylan Inc.611
已完成
2 期
MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0557-027)SchizophreniaParanoid SchizophreniaNCT00482430Merck Sharp & Dohme LLC50
Unknown
2 期
Phase 2a Obesity Study of Oral Doses of Oleoyl-Estrone (MP-101)ObesityNCT00449202Manhattan Pharmaceuticals100
已完成
2 期
A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)COPDNCT02040792Mylan Inc.355