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

NCT01906125 | Completed Phase 1

• 1 other identifier: A5481020
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; Cmax; AUC

Outcome Measures

Primary Outcomes (2)

• 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).

  7 days

• Maximum Observed Plasma Concentration (Cmax)

  7 days

Secondary Outcomes (6)

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

  7 days

• Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]

  7 days

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

  3 days

• Apparent Oral Clearance (CL/F)

  7 days

• Plasma Decay Half-Life (t1/2)

  7 days

Study Arms (1)

Palbociclib given to Healthy Volunteers

EXPERIMENTAL

Drug: palbociclib capsule: phase 1 and 2 studies; Drug: Palbociclib capsule: phase 3 studies; Drug: Palbociclib capsule: ICH

Interventions

palbociclib capsule: phase 1 and 2 studies DRUG

125 mg dose of palbociclib. Formulation used in phase 1 and 2 studies

Palbociclib given to Healthy Volunteers

Palbociclib capsule: phase 3 studies DRUG

125 mg dose of palbociclib. Formulation used in phase 3 studies

Palbociclib given to Healthy Volunteers

Palbociclib capsule: ICH DRUG

125 mg dose of palbociclib. Intended final market formulation

Palbociclib given to Healthy Volunteers

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
• Any condition possibly affecting drug absorption

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Overland Park, Kansas, 66212, United States

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
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: July 23, 2013
• Study Start: September 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 20, 2014

Record last verified: 2014-01

Locations

US (1)