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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by QDose Limited.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
QDose Limited
ClinicalTrials.gov Identifier:
NCT00426920
First received: January 24, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Drug: Insulin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by QDose Limited:

Primary Outcome Measures:
  • maximum insulin serum concentration
  • early T50%
  • late T50%
  • Tmax
  • AUC

Secondary Outcome Measures:
  • maximum glucose infusion rate
  • early T50%
  • late T50%
  • Tmax
  • AUC

Estimated Enrollment: 14
Study Start Date: February 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426920

Contacts
Contact: Marcus Hompesch, MD 619-427-1300
Contact: 24-hour emergency number 619-409-1277

Locations
United States, California
Profil Institute for Clinical Research Incorporated Not yet recruiting
Chula Vista, California, United States, 91911
Contact: Marcus hompesch, MD    619-427-1300      
Contact: 24-hour emergency number    619-409-1277      
Principal Investigator: Marcus Hompesch, MD         
Sponsors and Collaborators
QDose Limited
Investigators
Principal Investigator: Marcus Hompesch, MD Profil Institute for Clinical Research Incorporated
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00426920     History of Changes
Other Study ID Numbers: IOV/QD001
Study First Received: January 24, 2007
Last Updated: January 24, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by QDose Limited:
pharmacokinetics
pharmacodynamics
inhaled
recombinant human insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014