A Study to Determine if Technosphere® Inhalation Powder (FDKP) Causes ECG Changes (QTc) Following the Medication's Inhaled Administration.

This is an interventional treatment trial for Healthy Subjects focused on measuring Healthy males and females Read More

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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