Healthy
Conditions
Brief summary
The objective ot the present study is to obtain information about safety, tolerability and preliminary pharmacokinetics of BIII 890 CL after single intravenous administration of increasing doses in healthy male volunteers.
Interventions
DRUGBIII 890 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 subjects as determined by results of screening * Age ≥ 21 and ≤ 50 years * Broca index ≥ - 20% and ≤ + 20% * Signed written informed consent in accordance with Good Clinical Practice and local legislation
Exclusion criteria
* Results of the medical examination, laboratory tests or electrocardiogram recordings are judged by the clinical investigator to differ significantly from normal clinical values * Known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders * Volunteers with diseases of the central nervous system (such as epilepsy), central nervous system trauma in the medical history or with psychiatric disorders or neurological disorders * Known 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 the last month or less than ten half-lives of the respective drug before enrolment in the study * Intake of any other drugs 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 * Smokers (\> 10 cigarettes or 3 cigars or 3 pipes/day) * Volunteers who are not able to refrain from smoking on study days * Alcohol abuse (more than 60 g/day) * Drug abuse * Participation in excessive physical activities (e.g. competitive sports) within the last week before the study * Blood donation (≥ 100 ml) within the last 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with clinically relevant changes in vital signs | up to 8 days after drug administration |
| Number of subjects with adverse events | up to 8 days after drug administration |
| Number of subjects with clinically relevant changes in electrocardiogram | up to 8 days after drug administration |
| Number of subjects with clinically relevant changes in pharmaco electroencephalogram (EEG) | up to 24 hours after drug administration |
| Number of subjects with clinically relevant changes in laboratory parameters | up to 8 days after drug administration |
Secondary
| Measure | Time frame |
|---|---|
| Plasma clearance (CL) | up to 24 hours after drug administration |
| Maximum plasma concentration (Cmax) | up to 24 hours after drug administration |
| Amount of the analyte excreted in urine (Ae) | up to 24 hours after drug administration |
| Volume of distribution (Vz) | up to 24 hours after drug administration |
| Time to reach Cmax (tmax) | up to 24 hours after drug administration |
| Terminal half-life (t1/2) | up to 24 hours after drug administration |
| Area under the plasma concentration-time curve (AUC) for several time points | up to 24 hours after drug administration |
| Mean residence time (MRT) | up to 24 hours after drug administration |
Outcome results
None listed