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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mannkind Corporation
• Treatments: Moxifloxacin

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