A Study Designed to Determine if the Drugs Albuterol (Salbutamol) and Fluticasone Have an Effect on the Pharmacokinetics of the Investigational Product Technosphere® Insulin Inhalation Powder in Healthy Volunteers
Information source: Mannkind Corporation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus; Healthy Subjects
Intervention: Technosphere Insulin (TI) Inhalation Powder (Drug); Albuterol (Salbutamol) (Drug); Fluticasone (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mannkind Corporation Official(s) and/or principal investigator(s): Anders H. Boss, Study Chair, Affiliation: Mannkind Corporation
Summary
This study will investigate the effects of inhaled albuterol & fluticasone on one dose of
TI Inhalation Powder. A total of 12 eligible subjects will be enrolled.
Clinical Details
Official title: A Phase 1, Open-Label Study to Investigate the Effect of Albuterol (Salbutamol) and Fluticasone on the Pharmacokinetics of Inhaled Technosphere® Insulin Inhalation Powder in Healthy Subjects
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: PK parameters of serum insulin
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Subjects must have a fasting blood glucose (BG) level of less than 6. 1 mmol/L FEV1/ FVC =
LLN TLC = 80% Predicted DLco (unc) = 80% Predicted (Miller) No significant improvement in
pre- to post-bronchodilator spirometry (defined as an increase of = 12% and = 200 mL in
FEV1 or FVC) at Screening FEV1 = 80% (NHANES III Predicted
Exclusion Criteria:
History of diabetes mellitus Previous exposure to any inhaled insulin product Any known
pulmonary disease or inability to perform PFT maneuvers meeting recommended American
Thoracic Society (ATS) standards of acceptability and repeatability criteria Respiratory
tract infection within 8 weeks prior to Screening/Visit 1 Major organ system diseases
including seizures, heart failure, uncontrolled hypertension, aneurysm, cancer within the
past 5 years, liver disease, anemia or autoimmune disorder Clinically significant
abnormalities on screening laboratory evaluation Female subjects who are pregnant,
lactating, or planning to become pregnant during the clinical trial period or not
practicing adequate birth control Unable and/or unlikely to comprehend how to use the
investigational device in this study or to follow study instructions
Locations and Contacts
ICON Development Solutions, Manchester, United Kingdom, United Kingdom
Additional Information
Starting date: May 2008
Last updated: June 12, 2012
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