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

NCT ID: NCT00426920

Last Updated: 2007-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28

Brief Summary

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.

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Insulin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

QDose Limited

INDUSTRY

Sponsor Role: lead

Principal Investigators

Marcus Hompesch, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institute for Clinical Research Incorporated

Locations

Profil Institute for Clinical Research Incorporated

Chula Vista, California, United States

Countries

United States

Central Contacts

Marcus Hompesch, MD

Role: CONTACT

619-427-1300

24-hour emergency number

Role: CONTACT

619-409-1277

Facility Contacts

Marcus hompesch, MD

Role: primary

619-427-1300

24-hour emergency number

Role: backup

619-409-1277

Other Identifiers

IOV/QD001

Identifier Type: -

Identifier Source: org_study_id