Healthy
Conditions
Brief summary
The objective of the study is to obtain information about safety, tolerability and pharmacokinetics of BIIR 561 CL after single intravenous administration of increasing doses in healthy male volunteers
Interventions
DRUGBIIR 561 CL
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
MALE
Age
21 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male volunteers * Age 21 to 50 years * Broca index from -20% to +20% * Written informed consent prior to admission to the study
Exclusion criteria
* Medical examination, laboratory tests or ECG judged by the investigator to differ significantly from normal clinical values * Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Known diseases of the central nervous system (CNS) (such as epilepsy), CNS trauma in their medical history or with psychiatric or neurological disorders * Known history of orthostatic hypotension, fainting spells or blackouts * Chronic or relevant acute infections * 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 ten half-lives of the respective drug before enrolment in the study * Intake of any other drug which might influence the results of the trial during the week previous to the start of the study * Participation in another study with an investigational drug within the last two - months preceding this study * Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) * Alcohol use of more than 60 g per day * Drug dependency * Excessive physical activities (e.g. competitive sports) within the last week before the study * Blood donation within the last 4 weeks (\>= 100 ml)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events | up to 9 days after drug administration | — |
| Number of subjects with clinically significant findings in vital functions | up to 9 days after drug administration | blood pressure, pulse rate, respiratory rate, oral body temperature |
| Number of subjects with clinically significant findings in ECG | up to 9 days after drug administration | — |
| Number of subjects with clinically significant findings in EEG | up to 24 hours after drug administration | — |
| Number of subjects with clinically significant findings in laboratory tests | up to 9 days after drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Apparent terminal half-life (t1/2) | up to 24 hours after drug administration |
| Total clearance (CLtot) | up to 24 hours after drug administration |
| Volume of distribution during the terminal phase (Vz) | up to 24 hours after drug administration |
| Area under the concentration time curve (AUC) | up to 24 hours after drug administration |
| Renal clearance (CLR) | up to 24 hours after drug administration |
| Amount excreted into urine (Ae) | up to 24 hours after drug administration |
| Volume of distribution at steady state (Vss) | up to 24 hours after drug administration |
| Maximum drug plasma concentration (Cmax) | up to 24 hours after drug administration |
| Time to peak drug plasma concentration (tmax) | up to 24 hours after drug administration |
| Total mean residence time (MRTtot) | up to 24 hours after drug administration |
| Mean residence time of disposition (MRTdisp) | up to 24 hours after drug administration |
Outcome results
None listed