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To assess the safety, tolerance and pharmacokinetics of 5 mg to 2400 mg BILN 2061 ZW
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BILN 2061 ZW single rising doses | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| BILN 2061 ZW fixed dose fed | Experimental |
| |
| BILN 2061 ZW fixed dose fasted | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BILN 2061 ZW single rising doses | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with clinically relevant changes in vital signs (systolic and diastolic blood pressure, pulse rate) | Pre-dose, up to 48 hours after drug administration | |
| Changes from baseline in laboratory tests | Pre-dose and 48 hours after drug administration | |
| Number of patients with clinically relevant changes in 12-lead ECG | Pre-dose, up to 48 hours after drug administration | |
| Changes from baseline in physical examination | Pre-dose and 48 hours after drug administration | |
| Number of patients with adverse events | Up to 48 hours after drug administration | |
| Global assessment of tolerability by the investigator on a 4-point scale | Up to 48 hours after drug administration | |
| Maximum concentration of the analyte in plasma after a single dose administration (Cmax) | up to 48 hours after drug administration | |
| Area under the concentration-time curve of the analyte in plasma from time 0 to infinity (AUC0-infinity) | up to 48 hours after drug administration | |
| Time to reach Cmax following a single dose administration (tmax) | up to 48 hours after drug administration | |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| BILN 2061 ZW fixed dose | Drug |
|
| Standardized breakfast | Other |
|
| Elimination half-life of the analyte in plasma (t1/2) |
| up to 48 hours after drug administration |
| Total oral clearance of the analyte from plasma after oral administration, divided by F (bioavailability factor) (CL/F) | up to 48 hours after drug administration |
| Total mean residence time of the analyte in plasma (MRT) | up to 48 hours after drug administration |
| Apparent volume of distribution during the terminal elimination phase (Vz/F) | up to 48 hours after drug administration |
| Amount of intact drug excreted in urine (Au) | up to 48 hours after drug administration |
| ID | Term |
|---|---|
| C479555 | BILN 2061 |
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