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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

- Any condition possibly affecting drug absorption.

NCT02041273
Pfizer
Completed
Relative Bioavailability Of Palbociclib (PD-0332991) Under Fed And Fasted Conditions

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[email protected]

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Similar Trials

Relative Bioavailability Of Palbociclib (PD-0332991) Under Fed And Fasted Conditions
A Phase 1, Open-label 6 Sequence 3 Period Crossover Study of Palbociclib (PD- 0332991) in Healthy Volunteers to Estimate the Relative Bioavailability of Palbociclib Formulations
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • Drug: palbociclib isethionate (phase 1 and 2 studies)
    125 mg palbociclib isethionate salt under overnight fasting conditions
  • Drug: palbociclib isethionate (phase 1 and 2 studies)
    125 mg palbociclib isethionate salt under minimal fasting conditions (1 hr before palbociclib administration and 2 hrs post dose)
  • Drug: palbociclib commercial free base capsule
    125 mg palbociclib commercial free base capsule under fed conditions ( moderate fat meal)
Experimental: Palbociclib given to healthy volunteers
Interventions:
  • Drug: palbociclib isethionate (phase 1 and 2 studies)
  • Drug: palbociclib isethionate (phase 1 and 2 studies)
  • Drug: palbociclib commercial free base capsule
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
March 2014
March 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02041273
A5481036
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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