Status:
COMPLETED
A Study to Determine if Technosphere® Inhalation Powder (FDKP) Causes ECG Changes (QTc) Following the Medication's Inhaled Administration.
Lead Sponsor:
Mannkind Corporation
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 rando...
Detailed Description
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 FDK...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00721344
Start Date
April 1 2008
End Date
October 1 2008
Last Update
June 13 2012
Active Locations (1)
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1
Charles River Clinical Services Northwest
Tacoma, Washington, United States, 98418