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Trial record 41 of 729 for:    Area Under Curve AND Bioavailability

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

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ClinicalTrials.gov Identifier: NCT02041273
Recruitment Status : Completed
First Posted : January 22, 2014
Last Update Posted : March 17, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: palbociclib isethionate (phase 1 and 2 studies) Drug: palbociclib commercial free base capsule Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : January 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

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Arm Intervention/treatment
Experimental: Palbociclib given to healthy volunteers 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)




Primary Outcome Measures :
  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 7 days ]
    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).

  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 7 days ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  2. Apparent Oral Clearance (CL/F) [ Time Frame: 7 days ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  3. Plasma Decay Half-Life (t1/2) [ Time Frame: 7 days ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  4. Apparent Volume of Distribution (Vz/F) [ Time Frame: 7 days ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02041273


Locations
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United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02041273     History of Changes
Other Study ID Numbers: A5481036
First Posted: January 22, 2014    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014
Keywords provided by Pfizer:
bioavailability
bioequivalence
AUC
Cmax
Additional relevant MeSH terms:
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Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action