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

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)

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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)