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An Open-Label, Non-Randomized, Phase I Study to Assess the Absorption, Metabolism, and Excretion Following a Single Oral Dose of [14C]-Rucaparib in Patients With Advanced Solid Tumors (AME)
The purpose of this study is to characterize the mass balance, absorption, metabolism, and elimination pathways of orally administered \[14C\] rucaparib followed by cycle by cycle treatment with rucaparib continuing until disease progression or other reason for discontinuation
Details
| Lead sponsor | pharmaand GmbH |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 6 |
| Start date | 2016-11 |
| Completion | 2018-09 |
Conditions
- Solid Tumor
Interventions
- C-14 labeled Rucaparib
- Rucaparib
Primary outcomes
- Pharmacokinetics of 14C-labeled rucaparib (radioactivity in whole blood and plasma): tmax — Days 1-13
Time to peak concentration (tmax) - Pharmacokinetics of 14C-labeled rucaparib(Radioactivity in whole blood and plasma): Cmax — Days 1-13
peak (maximum) concentration (Cmax) - Pharmacokinetics of 14C-labeled rucaparib(Radioactivity in whole blood and plasma): t1/2 — Days 1-13
Elimination half-life (t1/2) - Pharmacokinetics of 14C-labeled rucaparib(Radioactivity in whole blood and plasma): AUC — Days 1-13
Area under curve (AUC) - Pharmacokinetics of 14C-labeled rucaparib(Radioactivity in whole blood and plasma): CL/F — Days 1-13
Oral clearance (CL/F) - Pharmacokinetics of 14C-labeled rucaparib(Radioactivity in whole blood and plasma): V/F — Days 1-13
Apparent volume of distribution (V/F)
Countries
Hungary