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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT02041273
A5481036

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

36 participants in 1 patient group

Palbociclib given to healthy volunteers
Experimental group
Treatment:
Drug: palbociclib commercial free base capsule
Drug: palbociclib isethionate (phase 1 and 2 studies)
Drug: palbociclib isethionate (phase 1 and 2 studies)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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