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About
This is a three stage, open label, randomized-sequence, single-crossover Phase 1 study to evaluate the relative bioavailability (BA) and Bioequivalence (BE) of niraparib administered as a tablet formulation compared to the reference capsule formulation currently marketed in the United States. Stage 3 evaluates the effect of a high-fat meal on niraparib pharmacokinetics (PK) following a single dose of the tablet. The Extension Phase of this study is to enable participants enrolled in the study to continue to receive treatment with niraparib tablets if they are tolerating it and, in the Investigator's opinion, may receive benefit.
Enrollment
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Inclusion and exclusion criteria
Key inclusion criteria:
PK Phase: To be considered eligible to participate in this study, all of the following requirements must be met:
Extension Phase:
Key Exclusion Criteria: PK Phase:
Primary purpose
Allocation
Interventional model
Masking
236 participants in 6 patient groups
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Data sourced from clinicaltrials.gov
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