Single Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Elderly Male and Female Volunteers

Study Overview
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Brief Summary
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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)

Official Title
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A Single-blind, Placebo-controlled Single Dose Tolerance Study in Healthy Elderly Male and Female Volunteers After Intravenous Administration of BIIR 561 CL as Loading Dose (Dosage: 75 mg/h, Infusion Time 1 Hour) Followed by Maintenance Dose (Dosage: 40 mg/h and 75 mg/h, Infusion Time 5 Hours)

Conditions
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Healthy

Intervention / Treatment
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* Drug: BIIR 561 CL
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIIR 561 CL<br> | Drug: BIIR 561 CL<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | up to 8 days after drug administration | 
| Number of subjects with clinically significant findings in vital functions | blood pressure, pulse rate, respiratory rate, oral body temperature | up to 8 days after drug administration | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum drug plasma concentration (Cmax) |  | 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 | 
| 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 | 
| Volume of distribution (Vz) |  | 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 |