NCT00757367

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)

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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 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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	TI Inhalation Powder	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.

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-09-23
• Last updated: 2013-12-17

Locations

1 site across 1 country: United States