Healthy
Conditions
Brief summary
The objective of the present study was to obtain information about the safety, tolerability and pharmacokinetics of BIIR 561 CL after continuous intravenous administration of two increasing doses in healthy elderly volunteers, following the infusion schema of a loading dose (1 hour) and a maintenance dose (5 hours)
Interventions
DRUGBIIR 561 CL
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female volunteers * Age \>= 60 years * Broca index from -25% to +25% * Written informed consent prior to admission to the study
Exclusion criteria
* Any finding of the medical examination (including blood pressure, pulse rate and Electrocardiogram (ECG)) deviating from normal and of clinical relevance * Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders (exclusion: substitution therapy regarding thyroid gland and/or ovaries) * Diseases of the central nervous system (CNS) (such as epilepsy) or psychiatric disorders or neurological disorders and medical history of such diseases or disorders * 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 drugs 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 drugs which might influence the results of the trial (\<= one week prior to administration or during the trial) * Participation in another trial with an investigational drug (\<= two months prior to administration or during the trial * Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day) * Inability to refrain from smoking on trial days * Alcohol abuse (\> 30g/day for males, \> 24 g for females) * Drug abuse * Blood donation (\>= 100 ml within four weeks prior to administration or during the trial) * Excessive physical activities (within the last week before the study) * Any laboratory value outside the reference range of clinical relevance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events | up to 8 days after drug administration | — |
| Number of subjects with clinically significant findings in vital functions | up to 8 days after drug administration | blood pressure, pulse rate, respiratory rate, oral body temperature |
| Number of subjects with clinically significant findings in ECG | up to 8 days after drug administration | — |
| Number of subjects with clinically significant findings in laboratory tests | up to 8 days after drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve extrapolated to infinity (AUC0-inf) | up to 32 hours after first drug administration |
| Mean residence time (MRT) | up to 32 hours after first drug administration |
| Plasma clearance (CL) | up to 32 hours after first drug administration |
| Maximum drug plasma concentration (Cmax) | up to 32 hours after first drug administration |
| Volume of distribution at steady state (Vss) | up to 32 hours after first drug administration |
| Amount excreted into urine (Ae) | up to 32 hours after first drug administration |
| Volume of distribution (Vz) | up to 32 hours after first drug administration |
| Time to Cmax (tmax) | up to 32 hours after first drug administration |
| Terminal half-life (t1/2) | up to 32 hours after first drug administration |
| Area under the plasma concentration-time curve from zero to the last time points with a quantifiable plasma concentration (AUC0-tf) | up to 32 hours after first drug administration |
Outcome results
None listed