NCT00721344已完成1 期
A Phase 1, Randomized, Double-Blind, Cross-Over, Placebo- and Active-Controlled Cardiac Safety Study of Therapeutic and Supratherapeutic Doses of Fumaryl Diketopiperazine Administered as Technosphere® Inhalation Powder 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
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The primary endpoint is the time-matched, placebo-subtracted change from baseline in QTc after a supratherapeutic dose of Technosphere Inhalation Powder
研究概览
简要总结
48 healthy adult male & female subjects will be enrolled in this study to determine the effect of Technosphere® Inhalation Powder (FDKP) on the QT interval of the EKG. Eligible subjects will be randomized into a dosing regimen after admission.
详细描述
This is a Phase 1, randomized, double-blind, cross-over, placebo- and active-controlled cardiac safety study in 48 healthy subjects (both male and female subjects) designed to assess the effect of FDKP on cardiac repolarization, if any, following introduction of Technosphere® Inhalation Powder via inhalation. Each trial subject will be administered 20 mg of FDKP, 40 mg of FDKP, 400 mg oral dose of moxifloxacin (active), and placebo in a crossover design during an 11 day in-patient stay.
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
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pulmonary Function Tests (PFTs) results within study specified limits.
- •Female subjects of childbearing potential must be non-pregnant and non-lactating and have a negative serum pregnancy test prior to enrollment into the trial.
- •Body Mass Index = 19 and = 30 kg/m2
- •Absence of recent drug or alcohol abuse
- •Able to provide written informed consent, follow study procedures and remain in-patient for the entire treatment period
- •Non-smoking (> 6 months)
排除标准
- •History of significant renal, pulmonary, rheumatological, hematological, neurological or psychiatrics disorder
- •Clinically significant major organ disease
- •Evidence or history of clinically significant allergies (except for untreated, asymptomatic, seasonal allergies at time of dosing);
- •Current or previous chemotherapy or radiation therapy that could cause lung toxicity
- •History of diabetes or taking any medications to treat diabetes
- •Clinically significant abnormal findings on physical exam, ECG, vital signs, clinical laboratory testing and medical history
- •Hypokalemia (calcium below lower limit of normal).
- •Previous exposure to Technosphere® Inhalation Powder
- •Participation in another clinical trial of an investigational drug or device within 30 days prior to Visit 3
- •Significantly excessive consumption of food or beverages with xanthine or caffeine
- •Unwilling to avoid alcohol 48 hours prior to study enrollment and during study
- •Unwilling to avoid strenuous activity for 48 hours prior to study enrollment and during study
- •Positive HIV or Hepatitis test
- •Any acute illness or fever within 72 hours of study dosing
- •Medication use (with exception of acetaminophen and hormonal birth control) or herbal use within 7 days of Visit 2
- •Unwillingness to remain in a quiet, controlled environment (i.e., no TV, music, games, etc during specific timepoints) or unwilling to remain supine during specific timepoints
- •Unwillingness to consume a study-specific diet
- •Blood donation within 8 weeks prior to Visit 2
- •History of chronic obstructive pulmonary disease (COPD), clinically proven asthma and/or any other clinically important pulmonary disease confirmed by pulmonary function testing and/or radiological finding
- •Active respiratory infection or persistent symptoms of such infection
- •History of risk factors for Torsades de pointes (TdP) [e.g., heart failure, hypokalemia, family history (parents or siblings) of Long QT Syndrome], history of fainting, unexplained loss of consciousness or convulsions
- •History of cardiac arrhythmia, of taking anti-arrhythmia drugs, significant cardiovascular dysfunction, myocardial dysfunction, cardiac surgery, transient attacks of ischemia or cerebrovascular accidents
- •An abnormal screening ECG which is interpreted by the Clinical Site Investigator to be clinically significant
- •Sustained supine resting systolic blood pressure > 140 mm Hg or < 100 mm Hg and /or diastolic blood pressure >95 mm Hg at study entry Baseline pulse rate of < 45 beats per minute or > 100 beats per minute
研究组 & 干预措施
1
Experimental
干预措施: Technosphere Inhalation Powder (FDKP) (Drug)
1
Experimental
干预措施: Moxifloxacin (Drug)
1
Experimental
干预措施: Placebo (Drug)
2
Experimental
干预措施: Technosphere Inhalation Powder (FDKP) (Drug)
2
Experimental
干预措施: Moxifloxacin (Drug)
2
Experimental
干预措施: Placebo (Drug)
3
Experimental
干预措施: Technosphere Inhalation Powder (FDKP) (Drug)
3
Experimental
干预措施: Moxifloxacin (Drug)
3
Experimental
干预措施: Placebo (Drug)
4
Experimental
干预措施: Technosphere Inhalation Powder (FDKP) (Drug)
4
Experimental
干预措施: Moxifloxacin (Drug)
4
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
The primary endpoint is the time-matched, placebo-subtracted change from baseline in QTc after a supratherapeutic dose of Technosphere Inhalation Powder
时间窗: 11 days
次要结局
- The time-matched change from baseline in QTc after therapeutic dose Technosphere® Inhalation Powder based on an individual correction (QTcI) method.(11 days)
- The maximum change in time-matched, placebo-subtracted QT interval corrected by Fridericia formula (QTcF) and Bazett formula (QTcB), respectively, for supratherapeutic dose of Technosphere® Inhalation Powder.(11 Days)
- The maximum change in time-matched, placebo-subtracted QT/QTc intervals by Fridericia formula (QTcF), and by Bazett formula (QTcB), respectively, for therapeutic dose of Technosphere® Inhalation Powder.(11 Days)
- Change in ECG morphological patterns(11 Days)
- Heart rate and RR interval.(11 Days)
- PR interval.(11 Days)
- QRS interval.(11 Days)
- Correlation between the QTcI change from baseline and plasma concentrations of FDKP.(11 Days)
- Plasma concentrations of FDKP.(11 Days)
研究者
研究点 (1)
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