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

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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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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