Expired Study
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Tacoma, Washington 98418


Purpose:

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.


Study summary:

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.


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 < 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


NCT ID:

NCT00721344


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Tacoma, Washington 98418
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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