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This study assesses the mass balance recovery, pharmacokinetics, metabolite profile and metabolite identification of defactinib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Defactinib treatment | Experimental | Single dose of 400 mg [14C]-defactinib, oral suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| defactinib | Drug | Single oral dose of 400 mg [14C]-defactinib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urine amount excreted (Ae) | Screening to 168h post-dose | |
| Urine fraction of the dose excreted (Fe) | Screening to 168h post-dose | |
| Urine cumulative amount excreted (Cum Ae) | Screening to 168h post-dose | |
| Urine cumulative fraction of the dose excreted (Cum Fe) | Screening to 168h post-dose | |
| Urine renal clearance (CLr) | Screening to 168h post-dose | |
| Faeces Ae | Screening to 168h post-dose | |
| Faeces Fe | Screening to 168h post-dose | |
| Faeces Cum Ae | Screening to 168h post-dose | |
| Faeces Cum Fe | Screening to 168h post-dose | |
| All excreta Ae | Screening to 168h post-dose | |
| All excreta Fe | Screening to 168h post-dose | |
| All excreta Cum Ae |
| Measure | Description | Time Frame |
|---|---|---|
| Time at which the analyte is first quantifiable (Tlag) | Screening to 168h post-dose | |
| Time from dosing at which Cmax is apparent (Tmax) | Screening to 168h post-dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hagop Youssoufian | Verastem, Inc. | Study Chair |
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| ID | Term |
|---|---|
| C584510 | defactinib |
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| Screening to 168h post-dose |
| All excreta Cum Fe | Screening to 168h post-dose |
| All excreta non-renal clearance (CLnr) | Screening to 168h post-dose |
| Maximum observed concentration (Cmax) |
| Screening to 168h post-dose |
| Area under the concentration vs. time curve from time zero extrapolated to last measurable concentration (AUC(0-last)) | Screening to 168h post-dose |
| Area under the concentration vs. time curve from time zero to infinity (AUC (0-inf)) | Screening to 168h post-dose |
| Percentage of AUC(0-inf) accounted for by extrapolation (AUC%extrap) | Screening to 168h post-dose |
| lamdba-z | Screening to 168h post-dose |
| Apparent elimination half-life (T1/2) | Screening to 168h post-dose |
| Mean residence time | Screening to 168h post-dose |
| Apparent clearance after oral administration (CL/F) | Screening to 168h post-dose |
| Apparent volume of distribution after oral administration (Vz/F) | Screening to 168h post-dose |