Food Effect On Pharmacokinetics Of Talazoparib Soft Gel Capsule Formulation in Advanced Solid Tumors
1-800-641-2422
A Phase 1, Open Label, Crossover Study to Establish Bioequivalence Between the Proposed Soft Gel Talazoparib Capsule Formulation and the Current Talazoparib Commercial Formulation and to Estimate the Food Effect on Pharmacokinetics of the Proposed Talazoparib Soft Gel Capsule Formulation in Participants with Advanced Solid Tumors
- Sex: Any
- Age: Adult (18 - 64), Older Adult (65+)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase I
- Conditions Being Studied: Cancer - Solid Tumor
Study Purpose
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.
- UH IRB: STUDY20201778
- StudyID: PFIZ1Y20
- ClinicalTrials.gov: NCT04672460
1-800-641-2422
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