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The objective of the study is to obtain information about safety, tolerability and pharmacokinetics of BIIR 561 CL after single intravenous administration of increasing doses in healthy male volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIR 561 CL | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIR 561 CL | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | up to 9 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 9 days after drug administration |
| Number of subjects with clinically significant findings in ECG | up to 9 days after drug administration | |
| Number of subjects with clinically significant findings in EEG | up to 24 hours after drug administration | |
| Number of subjects with clinically significant findings in laboratory tests | up to 9 days after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration time curve (AUC) | up to 24 hours after drug administration | |
| Maximum drug plasma concentration (Cmax) | up to 24 hours after drug administration | |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C119322 | irampanel |
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|
| Time to peak drug plasma concentration (tmax) |
| up to 24 hours after drug administration |
| Total mean residence time (MRTtot) | up to 24 hours after drug administration |
| Mean residence time of disposition (MRTdisp) | up to 24 hours after drug administration |
| Apparent terminal half-life (t1/2) | up to 24 hours after drug administration |
| Total clearance (CLtot) | up to 24 hours after drug administration |
| Volume of distribution during the terminal phase (Vz) | up to 24 hours after drug administration |
| Volume of distribution at steady state (Vss) | up to 24 hours after drug administration |
| Renal clearance (CLR) | up to 24 hours after drug administration |
| Amount excreted into urine (Ae) | up to 24 hours after drug administration |