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A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid Tumors

ABSTRACT: This will be a Phase 1, open label, 2-sequence, crossover study to establish the BE of the current commercial formulation (Generation 3.1 talazoparib capsules) to the proposed talazoparib liquid-filled soft gelatin capsule (soft gel capsule) formulation after multiple dosing under fasting conditions in participants with advanced solid tumors. In addition, the effect of food on the PK of the proposed talazoparib soft gel capsule formulation will be evaluated in fixed sequence after the 2 BE assessment periods.

DISEASE(S): Ovarian Cancer,Nsclc,Advanced Solid Tumors,Colorectal Cancer,Prostate Cancer,Pancreatic Cancer,Breast Cancer,Neoplasms,Solid Tumors

PROVIDER: 2361056 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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