A Study Comparing the Plasma Drug Exposure of an Oral Dose of Palbociclib (PD-0332991) to an Intravenous Dose of Palbociclib (PD-0332991)

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Intravenous Formulation of PD-0332991; Drug: Oral Drug Formulation of PD-0332991

Study type: Interventional

Funder types: Industry

Identifiers

NCT01802476

A5481015

QBR115052

Details and patient eligibility

About

The purpose of this study is to determine approximately what percentage of an orally administered dose of PD-0332991 is absorbed from the gastrointestinal tract into the systemic circulation. This approximation is made by comparing the plasma pharmacokinetics of a 125 mg oral dose of PD-0332991 to the plasma pharmacokinetics of a 50 mg intravenous dose of PD-0332991 administered as a 4-hour infusion.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male or female of non-childbearing potential between the ages of 18 and 55 years of age.
2. A body mass index (BMI) between 17.5 and 30.5 kg/m2, and a total body weight greater than 50kg (110 lbs)

Exclusion criteria

1. Any condition which could possibly affect drug absorption.
2. Pregnancy or actively nursing females, or females of childbearing potential.
3. A positive urine drug screen.

Trial design

14 participants in 1 patient group

Fixed Sequence Crossover Arm

Other group

Description:

This study arm consists of a fixed sequence crossover where study subjects will receive Treatment A and following a washout of no less than 10 days will then receive Treatment B. The drug class is a CDK4/6 inhibitor.

Treatment:

Drug: Oral Drug Formulation of PD-0332991

Drug: Intravenous Formulation of PD-0332991