Single Increasing Dose Followed by Maintenance Dose Tolerance Study of BIIR 561 CL in Healthy Male Volunteers

Study Overview
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Brief Summary
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The objective of the present study is to obtain information about the safety, tolerability and pharmacokinetics of BIIR 561 after continuous intravenous administration of increasing doses in healthy young volunteers

Official Title
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A Single-blind, Placebo-controlled Single Increasing Dose Tolerance Study in Healthy Male Volunteers After Intravenous Administration of BIIR 561 CL as Loading Dose (Dosage: 37.5 mg/h - 150 mg/h, Infusion Time 1 Hour) Followed by Maintenance Dose (Dosage: 20 mg/h - 40 to 125 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 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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

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 concentration in plasma (Cmax) |  | up to 32 hours after first drug administration | 
| Time to maximum concentration in plasma (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 | 
| Total Mean residence time (MRTtot) |  | up to 32 hours after first drug administration | 
| Total plasma clearance (CLtot) |  | 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 | 
| Mean residence time of disposition (MRTdisp) |  | up to 32 hours after first drug administration | 
| Renal clearance (CLR) |  | up to 32 hours after first drug administration |