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)

PHASE1CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

October 31, 2008

Study Completion Date

October 31, 2008

Conditions
Healthy Subjects
Interventions
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.

Trial Locations (1)

85006

PACT Pulmonary Associates, Phoenix

Sponsors
All Listed Sponsors
lead

Mannkind Corporation

INDUSTRY