OncRef

Clinical Trial: NCT04672460

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

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Pfizer
Information Provided By:Pfizer
Last Update Posted:2024-09-25

Study Overview

Brief Summary

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.

Official Title

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

Conditions

Advanced Solid Tumors, Solid Tumors, Ovarian Cancer, Breast Cancer, Prostate Cancer, NSCLC, Pancreatic Cancer, Colorectal Cancer

Intervention / Treatment

  • Drug: TALZENNA capsule
  • Drug: Talazoparib soft gel capsule
  • Drug: Talazoparib soft gel capsule

Other Study ID Numbers

  • C3441037
  • 2020-006101-35

Start Date (Actual)

2020-12-21

Primary Completion Date (Actual)

2022-02-04

Study Completion Date (Actual)

2022-07-22

Enrollment (Actual)

73

Study Type

Interventional

Phase

Phase 1