Healthy
Conditions
Brief summary
Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.
Interventions
DRUGBIIX 1 XX inhalation solution
single doses of 800, 1000, 1200, 1400, 1600, 1800, or 2000 mcg
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males, based on a complete medical examination * Age range from 21 to 50 years * Participant must be within +/- 20 % of their normal weight (Broca-Index) * Participant must provide written informed consent
Exclusion criteria
* Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram) or laboratory tests deviating from normal and of clinical relevance * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders * History of orthostatic hypotension, fainting spells or blackouts * Chronic or relevant acute infections * History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * Intake of a drug with a long half-life (≥ 24 hours) within at least one month or less than then half-lives of the respective drug before enrolment in the study * Use of any drugs which might influence the results of the trial within seven days prior to administration or during the trial * Participation in another trial with an investigational drug within two months prior to start of the study * Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) * Inability to refrain from smoking on study days * Alcohol abuse * Drug abuse * Blood donation (\> 100 ml) within four weeks prior to administration * Other disease or abnormality of clinical relevance * Excessive physical activities within two weeks prior to administration or during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with clinically relevant changes in safety laboratory parameters | up to 8 days after drug administration |
| Number of patients with clinically relevant changes in vital parameters (Blood pressure, Pulse rate) | up to 8 days after drug administration |
| Number of patients with clinically relevant changes in electrocardiogram (ECG) | up to 8 days after drug administration |
| Number of patients with clinically relevant changes in impedance cardiography | pre-dose, 10 and 30 minutes after administration |
| Number of patients with clinically relevant changes in cutaneous microcirculation | pre-dose, 10 and 30 minutes after administration |
| Number of patients with adverse events | up to 22 days |
Secondary
| Measure | Time frame |
|---|---|
| Area under the plasma drug concentration-time curve from zero time to the last time point of measurement (AUC0-tz) | up to 168 hours after drug administration |
| Terminal half-life of the analyte in plasma (t1/2) | up to 168 hours after drug administration |
| Clearance, divided by f (CL/f) | up to 168 hours after drug administration |
| Maximum concentration of the drug in plasma (Cmax) | up to 168 hours after drug administration |
Outcome results
None listed