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This non-randomized, single group, open-label study will investigate the mass balance, routes of elimination, pharmacokinetics, and metabolism of a single oral dose of RO5424802 and the pharmacokinetics of a 14C-labeled tracer in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RO5424802 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5424802 | Drug | Single oral doses followed by IV or oral administration of a 14C-labeled tracer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Elimination: Amount of drug excreted in urine/feces over the study period | Days 11 to 15 | |
| Pharmacokinetics: Bioavailability (Area under the plasma concentration-time curve [AUC]) after administration of RO5424802 | Days 1 to 25 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | Days 1 to 25 | |
| Pharmacokinetics: Metabolite identification in plasma, urine, and feces. | Days 11 to 25 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zuidlaren | 9471 GP | Netherlands |
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| ID | Term |
|---|---|
| C582670 | alectinib |
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