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

NCT00674050 | Completed Phase 1

• 1 other identifier: MKC-TI-114
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Healthy Subjects

Keywords

Healthy Males or Females subjects

Outcome Measures

Primary Outcomes (1)

• PK parameters of serum insulin

  0-360 min

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

Technosphere Insulin (TI) Inhalation Powder DRUG

3.0 U of human insulin. 5 or 10 mg or Technosphere Inhalation Powder, containing 15 0r 30 U of insulin.

1

Albuterol (Salbutamol) DRUG

2 puff= 200ug total dose

1

Fluticasone DRUG

2 puffs= 500ug total dose

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (1)

ICON Development Solutions

Manchester, United Kingdom, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Albuterol; Fluticasone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Anders H. Boss

  Mannkind Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 7, 2008
• Study Start: May 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2008
• Last Updated: June 13, 2012

Record last verified: 2012-06

Locations

GB (1)