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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Subjects

In brief

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.

Key facts

Study ID: NCT00721344
Run by: Mannkind Corporation
People needed: 48
Starts: 2008-04-01
Expected to finish: 2008-10-01
Last updated by the study team: 2012-06-13

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

Charles River Clinical Services Northwest — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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