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 - Tabular View

Tracking Information

First Received Date ^ICMJE

May 5, 2008

Last Updated Date

October 14, 2009

Start Date ^ICMJE

May 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

PK parameters of serum insulin [ Time Frame: 0-360 min ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00674050 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study

Condition ^ICMJE

Diabetes Mellitus
Healthy Subjects

Intervention ^ICMJE

Drug: Technosphere Insulin (TI) Inhalation Powder
Drug: Albuterol (Salbutamol)
Drug: Fluticasone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

October 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00674050

Responsible Party

Anders H. Boss, MD, MFPM, MannKind Corporation

Study ID Numbers ^ICMJE

MKC-TI-114

Study Sponsor ^ICMJE

Mannkind Corporation

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Anders H. Boss

Mannkind Corporation

Information Provided By

Mannkind Corporation

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP