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Safety and pharmacokinetics after oral single rising doses of BIIB 722 CL
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB 722 CL single rising dose | Experimental |
| |
| BIIB 722 CL cross over | Experimental |
| |
| Placebo solution | Placebo Comparator |
| |
| Placebo tablet | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB 722 CL solution | Drug |
| ||
| BIIB 722 CL tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of the analyte in plasma (AUC) | up to 96 hours after drug administration | |
| Maximum measured concentration of the analyte in plasma (Cmax) | up to 96 hours after drug administration | |
| Time from dosing to the maximum concentration of the analyte in plasma (tmax) | up to 96 hours after drug administration | |
| Total mean residence time of the analyte in the body (MRTtot) | up to 96 hours after drug administration | |
| Total clearance of the analyte in plasma (CLtot/f) | up to 96 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | up to 96 hours after drug administration | |
| Number of subjects with clinically significant findings in vital functions | up to 96 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D012996 | Solutions |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D004304 | Dosage Forms |
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| Drug |
|
| Placebo solution | Drug |
|
| Placebo tablet | Drug |
|
| Number of subjects with clinically significant findings in laboratory tests | up to 96 hours after drug administration |
| Thrombocytic Na-H exchange (NHE-1) inhibition by AUC of pH recovery | up to 24 hours after drug administration |