A Phase 1 bioequivalence study between the current commercial formulation & the proposed soft gel capsule formulation of talazoparib & food effect study for the proposed talazoparib soft gel capsule formulation in participants w/ advanced solid tumors

Brief description of study

The purpose of the study is to establish whether there is same effect 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. The study drug talazoparib is a potent, orally bioavailable,small molecule poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor (PARPi) that is in development for the treatment of a variety of human cancers. The study drug talazoparib is investigational, which means that it has not been approved by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test this agent in the current trial.

Clinical Study Identifier: s20-02047
ClinicalTrials.gov Identifier: NCT04672460

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