Increasing Dose Tolerance Study in Healthy Male Volunteers After Administration of BIII 890 CL

Study Overview
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Brief Summary
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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.

Official Title
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A Single-blind, Placebo-controlled, Parallel Group, Single Increasing Dose Tolerance Study in Healthy Male Volunteers After Intravenous Administration of BIII 890 CL (Dosage: 0.5 mg/h - 80 mg/h), Infusion Time 1 Hour.

Conditions
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Healthy

Intervention / Treatment
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* Drug: BIII 890 CL
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

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: BIII 890 CL<br>single increasing doses | Drug: BIII 890 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 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) |  | 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 | 
| Plasma clearance (CL) |  | up to 24 hours after drug administration | 
| Volume of distribution (Vz) |  | up to 24 hours after drug administration | 
| Amount of the analyte excreted in urine (Ae) |  | up to 24 hours after drug administration |