Status:
COMPLETED
A Trial to Determine How Long Insulin and FDKP (the Molecule That Forms Technosphere Particles) Stays in the Lungs of Healthy Individuals After Inhalation of Technosphere® Insulin (TI) Powder Using Bronchoalveolar Lavage (BAL)
Lead Sponsor:
Mannkind Corporation
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Lavage fluid (BAL) is inserted into a lung lobe using a flexible bronchoscope. The fluid is aspirated out to remove any remaining TI. It's performed twice at specific time points in 12 healthy volunte...
Detailed Description
Informed consent and eligibility occur at Screening. Dosing is at Visit 2. Blood glucose levels are monitored and adjusted using IV infusion of glucose. Bronchoalveolar lavage (BAL) is performed at 30...
Eligibility Criteria
Inclusion
- Nonsmokers for greater than or equal to 12 months
- Normal chest x-ray (CXR) at Screening/Visit 1
- Prebronchodilator FEV1 greater than or equal to 80% Third National Health and Nutrition Examination Survey (NHANES) III Predicted
- Prebronchodilator FEV1/FVC greater than or equal to LLN% NHANES III Predicted
- Prebronchodilator total lung capacity (TLC) greater than or equal to 80% of Predicted Intermountain Thoracic Society (ITS)
- Prebronchodilator Dlco (unc) greater than or equal to 80% Predicted (Miller)
- Written Informed Consent
Exclusion
- History of diabetes mellitus
- Previous exposure to TI Inhalation Powder within 3 months of Visit 1, or exposure to any other inhaled insulin product
- Allergy or known hypersensitivity to insulin or to any of the drugs to be used in the trial or a history of hypersensitivity to TI Inhalation Powder or to drugs with a similar chemical structure.
- History of chronic obstructive pulmonary disease (COPD), asthma, and or any other clinically important pulmonary disease (eg, cystic fibrosis, bronchiectasis, and/or sleep apnea) confirmed by PFTs and/or radiologic findings.
- Known allergic or adverse reactions to specified medications
- Seizure disorder, significant cardiovascular dysfunction and/or history within 3 months of Visit 1, uncontrolled hypertension, known history of aortic or cerebral aneurysm, renal dysfunction or disease, serum creatinine \> 2.0 mg/dL in males and \> 1.8 mg/dL in females and/or blood urea nitrogen (BUN) \> 50 mg/dL
- Cancer (other than excised cutaneous basal cell carcinoma) within the past 5 years or any history of lung neoplasms.
- History of active viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes, as evidenced by serum aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT) ? 3x upper limit of normal (ULN).
- Active infection (eg, human immunodeficiency virus (HIV), hepatitis) or history of severe infection within 30 days of Visit 1
- Anemia (hemoglobin value ? 10.5 g/dL for females or ? 11.5 g/dL for males.
- Diagnosis of systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine.
- Current or previous chemotherapy, radiation therapy, or amiodarone use that may result in pulmonary toxicity.
- Clinically significant abnormalities or screening laboratory evaluation (unless approved by the Medical Monitor).
- Female subjects who are pregnant, lactating, or planning to become pregnant during the clinical trial period.
- Female subjects of childbearing potential not practicing adequate birth control.
- Current drug or alcohol abuse or a history of drug or alcohol abuse, that, in the opinion of the PI, would not make the subject a suitable candidate for participation in the clinical trial.
- Exposure to any investigational medications or devices within the previous 30 days prior to trial entry or participation in another clinical trial while participating in the clinical trial.
- Unable and/or unlikely to comprehend and/or follow the trial protocol.
- Unable and/or unlikely to comprehend how to use the MedTone Inhaler Model D or inability to properly use the device.
- A lack of compliance with medication or procedures, that, in the PI's opinion, may affect the clinical trial data or the subject's safety and which precludes the subject from further participation in the clinical trial
- Any other concurrent medical or major psychiatric condition that, in the opinion of the PI, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent, and/or impair the subject's ability to participate in the trial.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00757367
Start Date
July 1 2008
End Date
October 1 2008
Last Update
December 17 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
PACT Pulmonary Associates
Phoenix, Arizona, United States, 85006