Investigating the Pharmacokinetics and Pharmacodynamics of Recombinant Human Insulin Administered by Dry Powder Inhaler

January 24, 2007 updated by: QDose Limited

Evaluation of the Pharmacokinetics and Pharmacodynamics of Spray-Dried Recombinant Human Insulin Powder for Inhalation Administered Via a Dry Powder Inhalation Device Relative to SC Recombinant Human Insulin in Healthy Male Volunteers

Evaluation of the pharmacokinetics and pharmacodynamics of different doses of spray-dried recombinant human insulin powder for inhalation administered via a dry powder uinhalation device compared with subcutaneously administered regular human insulin in healthy male volunteers under the conditions of a eugycemic clamp.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Explorative, single-center, randomized, open label, 4-way crossover study to evaluate the pharmacokinetics and pharmacodynamics of different doses of spray-dried recombinant human insulin powder for inhalation administered via a dry powder uinhalation device compared with subcutaneously administered regular human insulin in healthy male volunteers under the conditions of a eugycemic clamp.

Study Type

Interventional

Enrollment

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Marcus hompesch, MD
  • Phone Number: 619-427-1300

Study Contact Backup

  • Name: 24-hour emergency number
  • Phone Number: 619-409-1277

Study Locations

  • United States
    • California
      • Chula Vista, California, United States, 91911
        • Profil Institute for Clinical Research Incorporated
        • Contact:
          • Marcus hompesch, MD
          • Phone Number: 619-427-1300
        • Contact:
          • 24-hour emergency number
          • Phone Number: 619-409-1277

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • male
  • non smoking for at least 12 months
  • BMI equal to or less than 28
  • no clinically significant abnormalities
  • FVC and FEV1 equal to or more than 80%
  • willing to participate and to sign informed consent form

Exclusion Criteria:

  • positive results for insulin antibodies at screening
  • history of substance abuse or dependency within last 5 years
  • positive screening test for substance abuse
  • positive blood test for HIV, hepatitis B or hepatitis C antibody
  • fasting blood glucose of more than 126mg/dl
  • any existing medical conditions which might interfere with absoprtion, distribution, metabolism or excretion of study medication
  • history of bronchospastic disease(asthma), tachycardia, migraine headache, hypoglycemic episodes, jaundice, liver diseases, arterial hemorrhaging, severe hypertension or hypotension, cardiac abnormality, renal disease, allergies, unresolved psychiatric illness, drug-induced myopathy or any other clinically significant abnormality
  • has received investigational medications within 21 days prior to receiving the first dose of study medication
  • has taken or used any prescription medications within 21 days prior to receiving the first dose of study medication
  • has taken or used any OTC medications,vitamins or herbal and/or nutritional supplements within 10 days days prior to receiving the first dose of study medication
  • health that may be adversely affected by procedures or medications used in the study
  • unwillingness or inability to understand or to follow required study restrictions and procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
maximum insulin serum concentration
early T50%
late T50%
Tmax
AUC

Secondary Outcome Measures

Outcome Measure
early T50%
late T50%
Tmax
AUC
maximum glucose infusion rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QDose Limited

Investigators

  • Principal Investigator: Marcus Hompesch, MD, Profil Institute for Clinical Research Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Study Registration Dates

First Submitted

January 24, 2007

First Submitted That Met QC Criteria

January 24, 2007

First Posted (Estimate)

January 25, 2007

Study Record Updates

Last Update Posted (Estimate)

January 25, 2007

Last Update Submitted That Met QC Criteria

January 24, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOV/QD001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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