Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | PHASE1 | COMPLETED | 13 | — | — | Jul 1, 2008 | Oct 1, 2008 | Dec 17, 2013 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| TI Inhalation Powder | EXPERIMENTAL | TI Inhalation Powder, single dose, 60 units |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * 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 eq...