a study to determine if technosphere® inhalation powder (fdkp) causes ecg changes (qtc) following the medication's inhaled administration.

Conditions: Healthy Subjects

Summary: 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.

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.

Eligibility criteria:
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 \ 95 mm hg at study entry baseline pulse rate of \ 100 beats per minute

Keywords: healthy males and females