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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01802476
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arm: 1
• Duration (Months): 1
• Patients Per Site Per Month: 13.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Oral Drug Formulation of PD-0332991; Drug: Intravenous Formulation of PD-0332991	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1, Single Dose, Fixed Sequence, 2-Period Cross-Over Absolute Oral Bioavailability Study In Healthy Volunteers Comparing Oral To Intravenous Administration Of PD-0332991
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: Fixed Sequence Crossover Arm 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; Treatment A consists of a single 125 mg oral dose of PD-0332991.; Drug: Intravenous Formulation of PD-0332991; Treatment B consists of a 1000 mL intravenous infusion of 50 mg of PD-0332991 administered over 4 hours at a constant rate.

Outcome Measures

Primary Outcome Measures

1. Dose-Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [0 to 144 hours]

   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).

2. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [0 to 144 hours]

   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).

Secondary Outcome Measures

1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [0 to 144 hours]

   Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

2. Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [0 to 144 hours]

   Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by the administered dose.

3. Maximum Observed Plasma Concentration (Cmax) [0 to 144 hours]

4. Dose-Normalized Maximum Observed Plasma Concentration (Cmax) [0 to 144 hours]

   The maximum observed plasma concentration divided by the administered dose.

5. Time to Reach Maximum Observed Plasma Concentration (Tmax) [0 to 144 hours]

6. Plasma Decay Half-Life (t1/2) [0 to 144 hours]

   Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

7. Systemic Clearance (CL) [0 to 144 hours]

   CL is a quantitative measure of the rate at which a drug substance is removed from the body following an intravenous dose.

8. Apparent Oral Clearance (CL/F) [0 to 144 hours]

   Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

9. Apparent Volume of Distribution after an Oral Dose (Vz/F) [0 to 144 hours]

10. Volume of Distribution at Steady State after an IV Infusion (Vss) [0 to 144 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	NOttingham	Nottinghamshire	United Kingdom	NG11 6JS

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01802476
• Other Study ID Numbers: A5481015; QBR115052
• First Posted: Mar 1, 2013
• Last Update Posted: Dec 17, 2013
• Last Verified: Dec 1, 2013

• Keywords provided by Pfizer: PD-0332991; Absolute Bioavailability Study
• Additional relevant MeSH terms: Palbociclib

Study Results

No Results Posted as of Dec 17, 2013