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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01802476
• Other study ID #: A5481015
• Secondary ID: QBR115052
• Status: Completed
• Phase: Phase 1
• First received: February 27, 2013
• Last updated: December 16, 2013
• Start date: May 2013
• Est. completion date: June 2013

Study information

• Verified date: December 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Oral Drug Formulation of PD-0332991
Treatment A consists of a single 125 mg oral dose of PD-0332991.
• 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.

Locations

Country	Name	City	State
United Kingdom	Pfizer Investigational Site	NOttingham	Nottinghamshire

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	0 to 144 hours	No
Secondary	Dose-Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) divided by the administered dose.	0 to 144 hours	No
Secondary	Maximum Observed Plasma Concentration (Cmax)		0 to 144 hours	No
Secondary	Dose-Normalized Maximum Observed Plasma Concentration (Cmax)	The maximum observed plasma concentration divided by the administered dose.	0 to 144 hours	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		0 to 144 hours	No
Secondary	Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	0 to 144 hours	No
Secondary	Systemic Clearance (CL)	CL is a quantitative measure of the rate at which a drug substance is removed from the body following an intravenous dose.	0 to 144 hours	No
Secondary	Apparent Oral Clearance (CL/F)	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.	0 to 144 hours	No
Secondary	Apparent Volume of Distribution after an Oral Dose (Vz/F)		0 to 144 hours	No
Secondary	Volume of Distribution at Steady State after an IV Infusion (Vss)		0 to 144 hours	No

External Links

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