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)

NCT00757367 | Completed Phase 1

• 1 other identifier: MKC-TI-122
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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 volunteers. BAL fluid will be analyzed for insulin and FDKP.

Conditions

Healthy Subjects

Keywords

Healthy subjects; insulin; bronchoscope; serum insulin; serum C-Peptide; BAL fluid; FDKP

Outcome Measures

Primary Outcomes (1)

• Estimation of the amount of insulin in the lungs and amount of FDKP by analyzing BAL fluid, obtained by a flexible fiber optic bronchoscope at various time points after admin of TI Inhalation Powder.

  2 Months

Study Arms (1)

TI Inhalation Powder

EXPERIMENTAL

TI Inhalation Powder, single dose, 60 units

Drug: TI Inhalation Powder

Interventions

TI Inhalation Powder DRUG

1 60-U dose of TI Inhalation Powder before the bronchoscopy. Cohort 1 will undergo bronchoscopies at 30 minutes and again at 6 hours after the 60-U dose inhalation of TI Inhalation Powder. Cohort 2 bronchoscopies will occur at 4 hours and again at 8 hours after TI Inhalation Powder. The need to run and the timepoints for bronchoscopies for Cohort 3 will be determined based on the results from Cohort 1 and 2. All subjects will undergo 2 bronchoscopies at Visit 2.

TI Inhalation Powder

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (1)

PACT Pulmonary Associates

Phoenix, Arizona, 85006, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Anders Boss, MD, MPH

  Mannkind Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2008
• First Posted: September 23, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

US (1)