A Study To Establish The Equivalence Of 2 Palbociclib (PD-0332991) Formulations To The Intended Final Market Product

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01906125
• Collaborator: (none)
• Enrollment: 73
• Location: 1
• Arm: 1
• Duration (Months): 4
• Patients Per Site Per Month: 18.2

Study Details

Study Description

Brief Summary

This study is intended to establish the equivalence of 2 formulations to the intended final market product. The formulations to compare are the capsule given to patients in the phase I and II studies and the capsule that is being administered to the patients in the phase III trials. Both capsules will be compared to the intended final market capsule. The comparison will be performed looking at the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing these parameters calculated after a single 125 mg dose of the 3 capsules identifying like that if there are significant differences between these 3 formulations.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: palbociclib capsule: phase 1 and 2 studies; Drug: Palbociclib capsule: phase 3 studies; Drug: Palbociclib capsule: ICH	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1, Open-Label 3 Sequence 3 Period Crossover Study Of Palbociclib (PD-0332991) In Healthy Volunteers To Establish The Bioequivalence Of The Phase 1/2 And Phase 3 Formulation To Palbociclib ICH Formulation Under Fasted Conditions
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Palbociclib given to Healthy Volunteers	Drug: palbociclib capsule: phase 1 and 2 studies; 125 mg dose of palbociclib. Formulation used in phase 1 and 2 studies; Drug: Palbociclib capsule: phase 3 studies; 125 mg dose of palbociclib. Formulation used in phase 3 studies; Drug: Palbociclib capsule: ICH; 125 mg dose of palbociclib. Intended final market formulation

Outcome Measures

Primary Outcome Measures

1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [7 days]

   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).

2. Maximum Observed Plasma Concentration (Cmax) [7 days]

Secondary Outcome Measures

1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [7 days]

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

2. Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [7 days]

   AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)

3. Area Under the Curve From Time Zero to 72 hrs [AUC (0-72)] [3 days]

   AUC (0-72)= Area under the plasma concentration versus time curve from time zero (pre-dose) to 72 hrs(0-72)

4. Apparent Oral Clearance (CL/F) [7 days]

   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.

5. Plasma Decay Half-Life (t1/2) [7 days]

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

6. Apparent Volume of Distribution (Vz/F) [7 days]

   Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years

• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

• Any condition possibly affecting drug absorption

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Overland Park	Kansas	United States	66212

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: NCT01906125
• Other Study ID Numbers: A5481020
• First Posted: Jul 23, 2013
• Last Update Posted: Jan 20, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Pfizer: Bioequivalence; Cmax; AUC
• Additional relevant MeSH terms: Palbociclib

Study Results

No Results Posted as of Jan 20, 2014