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The aims of this phase I study are to define the metabolism, excretion and pharmacokinetics of [14C]-BIIL 284 BS after administration of a single oral dose of 25 mg [14C]-BIIL 284 BS in 6 healthy volunteers. Tolerability was also assessed.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] BILL 284 BS | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Rates and routes of excretion of total radioactivity | up to 216 hours after drug administration | |
| Concentration of [14C] radioactivity in blood | up to 216 hours after drug administration | |
| Concentration of [14C] radioactivity in excreta (urine, faeces) | up to 216 hours after drug administration | |
| Maximum concentration of the analytes in plasma (Cmax) | up to 216 hours after drug administration | |
| Time to reach Cmax (tmax) | up to 216 hours after drug administration | |
| Terminal half-life (t1/2) | up to 216 hours after drug administration | |
| Mean residence time (MRT) | up to 216 hours after drug administration | |
| Area under the drug concentration-time curve extrapolated from zero to infinity (AUC0-inf) | up to 216 hours after drug administration | |
| Apparent clearance (CL/f) | up to 216 hours after drug administration | |
| Volume of distribution (Vd/f) | up to 216 hours after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with clinically significant changes in laboratory parameters | up to 216 hours after drug administration | |
| Number of subjects with clinically significant findings in physical examination | up to 216 hours after drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Nature of metabolites in plasma | up to 8 hours after drug administration |
| Nature of metabolites in urine | up to 48 hours after drug administration |
| Nature of metabolites in faeces | up to 48 hours after drug administration |
| Excretion balance on the basis of the [14C] radioactivity in urine and faeces | up to 216 hours after drug administration |
| Number of subjects with clinically significant changes in vital signs | up to 216 hours after drug administration |
| Number of subjects with clinically significant findings in 12-lead electrocardiogram | up to 216 hours after drug administration |
| Number of subjects with adverse events | up to 216 hours after drug administration |