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

NCT01802476 | Completed Phase 1

• 2 other identifiers: A5481015QBR115052
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

PD-0332991; Absolute Bioavailability Study

Outcome Measures

Primary Outcomes (2)

• Dose-Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

  Dose-Normalized AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8) divided by the administered dose. It is obtained from AUC (0 - t) plus AUC (t - 8).

  0 to 144 hours

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

  AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).

  0 to 144 hours

Secondary Outcomes (10)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  0 to 144 hours

• Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  0 to 144 hours

• Maximum Observed Plasma Concentration (Cmax)

  0 to 144 hours

• Dose-Normalized Maximum Observed Plasma Concentration (Cmax)

  0 to 144 hours

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  0 to 144 hours

Study Arms (1)

Fixed Sequence Crossover Arm

OTHER

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.

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

Interventions

Oral Drug Formulation of PD-0332991 DRUG

Treatment A consists of a single 125 mg oral dose of PD-0332991.

Fixed Sequence Crossover Arm

Intravenous Formulation of PD-0332991 DRUG

Treatment B consists of a 1000 mL intravenous infusion of 50 mg of PD-0332991 administered over 4 hours at a constant rate.

Fixed Sequence Crossover Arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2013
• First Posted: March 1, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

GB (1)