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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIII 890 CL | Experimental | single increasing doses |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIII 890 CL | Drug |
| ||
| Placebo |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| C408069 | BIII 890 CL |
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|
| 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 |