Clinical Trials Directory

Trials / Completed

CompletedNCT04672460

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

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
73 (actual)
Sponsor
Pfizer · Industry
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGTALZENNA capsuleCurrent commercial talazoparib formulation 1 mg once daily given under fasting condition
DRUGTalazoparib soft gel capsuleProposed talazoparib soft gel capsule formulation 1 mg once daily under fasting condition
DRUGTalazoparib soft gel capsuleProposed talazoparib soft gel capsule formulation 1 mg once daily under fed condition

Timeline

Start date
2020-12-21
Primary completion
2022-02-04
Completion
2022-07-22
First posted
2020-12-17
Last updated
2024-09-25
Results posted
2024-09-25

Locations

31 sites across 2 countries: United States, Australia

Regulatory

Source: ClinicalTrials.gov record NCT04672460. Inclusion in this directory is not an endorsement.