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

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