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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00426920
• Other study ID #: IOV/QD001
• Status: Not yet recruiting
• Phase: Phase 1
• First received: January 24, 2007
• Last updated: January 24, 2007
• Start date: February 2007

Study information

• Verified date: January 2007
• Source: QDose Limited
• Contact: Marcus Hompesch, MD
• Phone: 619-427-1300
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 14
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Insulin

Locations

Country	Name	City	State
United States	Profil Institute for Clinical Research Incorporated	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
QDose Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum insulin serum concentration
Primary	early T50%
Primary	late T50%
Primary	Tmax
Primary	AUC
Secondary	maximum glucose infusion rate
Secondary	early T50%
Secondary	late T50%
Secondary	Tmax
Secondary	AUC