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Sponsored by: |
Mannkind Corporation |
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Information provided by: | Mannkind Corporation |
ClinicalTrials.gov Identifier: | NCT00757367 |
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.
Condition | Intervention | Phase |
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Healthy Subjects |
Drug: TI Inhalation Powder |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | A Phase 1, Open-Label, Controlled Clinical Trial to Determine the Pulmonary Residence Time of Insulin and Fumaryl Diketopiperazine, Utilizing Bronchoalveolar Lavage, After Administration of Technosphere® Insulin Inhalation Powder in Healthy Subjects |
Enrollment: | 13 |
Study Start Date: | July 2008 |
Study Completion Date: | October 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
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 minutes and 6 hours for Cohort 1 and at 4 and 8 hours for Cohort 2, post TI dose. A series of blood samples are taken at specified timepoints. Cohort 3 will proceed with dosing if deemed necessary once analysis of BAL from Cohorts 1 & 2 is performed. Visit 3 is the follow-up safety visit.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | MannKind Corporation ( Anders Boss, Chief Medical Officer & Senior Vice President ) |
Study ID Numbers: | MKC-TI-122 |
Study First Received: | September 22, 2008 |
Last Updated: | May 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00757367 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Healthy subjects insulin bronchoscope serum insulin |
serum C-Peptide BAL fluid FDKP |
Hypoglycemic Agents Healthy Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Insulin |