Diabetes Mellitus
Conditions
Keywords
pharmacokinetics, pharmacodynamics, inhaled, recombinant human insulin
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.
Interventions
DRUGInsulin
Sponsors
QDose Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC | — |
| maximum insulin serum concentration | — |
| early T50% | — |
| late T50% | — |
| Tmax | — |
Secondary
| Measure | Time frame |
|---|---|
| maximum glucose infusion rate | — |
| early T50% | — |
| late T50% | — |
| Tmax | — |
| AUC | — |
Countries
United States
Contacts
Primary ContactMarcus Hompesch, MD
Backup Contact24-hour emergency number
Outcome results
None listed