Clinical trial NCT00426920: Investigating the Pharmacokinetics and Pharmacodynamics of Recombinant Human Insulin Administered by Dry Powder Inhaler
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetes Mellitus
Keywords: pharmacokinetics
pharmacodynamics
inhaled
recombinant human insulin
Lead sponsor: QDose Limited
Sponsor class: INDUSTRY
First posted: 2007-01-25
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: maximum insulin serum concentration
measure: early T50%
measure: late T50%
measure: Tmax
measure: AUC
Secondary outcomes:
measure: maximum glucose infusion rate
measure: early T50%
measure: late T50%
measure: Tmax
measure: AUC
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Profil Institute for Clinical Research Incorporated
state: California
Study officials:
affiliation: Profil Institute for Clinical Research Incorporated
name: Marcus Hompesch, MD
role: PRINCIPAL_INVESTIGATOR
References: