Relative Bioavailability Of Palbociclib (PD-0332991) Under Fed And Fasted Conditions

NCT02041273 | Completed Phase 1

• 1 other identifier: A5481036
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

A relative bioavailability study of commercial palbociclib free base hard capsules to the isethionate salt palbociclib capsules ( used in Phase 1 and 2 studies) under different fasting conditions.

Conditions

Healthy

Keywords

bioavailability; bioequivalence; AUC; Cmax

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 (4)

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

  7 days

• Apparent Oral Clearance (CL/F)

  7 days

• Plasma Decay Half-Life (t1/2)

  7 days

• Apparent Volume of Distribution (Vz/F)

  7 days

Study Arms (1)

Palbociclib given to healthy volunteers

EXPERIMENTAL

Drug: palbociclib isethionate (phase 1 and 2 studies); Drug: palbociclib commercial free base capsule

Interventions

palbociclib isethionate (phase 1 and 2 studies) DRUG

125 mg palbociclib isethionate salt under overnight fasting conditions

Palbociclib given to healthy volunteers

palbociclib commercial free base capsule DRUG

125 mg palbociclib commercial free base capsule under fed conditions ( moderate fat meal)

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

New Haven, Connecticut, 06511, United States

Location

Related Links

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

MeSH Terms

Interventions

Clinical Trials, Phase I as Topic

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

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: January 14, 2014
• First Posted: January 22, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 17, 2014

Record last verified: 2014-03

Locations

US (1)