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Study to assess safety, pharmacodynamics and pharmacokinetics of BIIB 722 CL
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB 722 CL | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB 722 CL | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma (AUC) | up to day 7 | |
| Maximum measured concentration of the analyte in plasma (Cmax) | up to day 7 | |
| Time to maximum measured concentration of the analyte in plasma (tmax) | up to day 7 | |
| Total mean residence time of the analyte in the body (MRTtot) | up to day 7 | |
| Total clearance of the analyte in plasma (CLtot/f) | up to day 7 | |
| Terminal half-life of the analyte in plasma (t1/2) | up to day 7 | |
| Amount of the analyte excreted in urine (Ae) | up to day 7 | |
| Dose proportionality | assessed by AUC | up to day 7 |
| Accumulation factor | (predose concentration/concentration after 8 hours) | up to day 7 |
| Time to reach steady state | up to day 7 | |
| Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | up to day 12 | |
| Number of subjects with clinically significant findings in vital functions | up to day 12 | |
| Number of subjects with clinically significant findings in laboratory tests |
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Inclusion Criteria:
Exclusion Criteria:
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|
in vitro fluorescence |
| up to day 7 |
| up to day 12 |