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Trial record 56 of 729 for:    Area Under Curve AND Bioavailability

Relative Bioavailability For Palbociclib Formulations

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ClinicalTrials.gov Identifier: NCT02083640
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : June 4, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This study is to assess the relative bioavailability of palbociclib hard gelatin capsule formulation (API 41 micrometer and dissolution Level 1) and palbociclib hard gelatin capsule formulation (API 16 micrometer and dissolution Level 2) compared to the palbociclib hard gelatin capsule formulation (API 16 micrometer and dissolution Level 1) after single 125 mg oral doses under fed conditions in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: Palbociclib Formulation Reference Drug: Palbociclib Formulation Test Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover 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 3 Palbociclib Formulations
Study Start Date : March 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Palbociclib

Arm Intervention/treatment
Treatment A (Reference) Drug: Palbociclib Formulation Reference
125 mg single dose of palbociclib formulation with 16 micrometer API particle size and dissolution level 1, which is representative of the intended commercial hard gelatin capsule.

Treatment B (Test) Drug: Palbociclib Formulation Test
125 mg single dose of palbociclib formulation with 41 micrometer API particle size and dissolution level 1

Treatment C (Test) Drug: Palbociclib Formulation Test
125 mg single dose of palbociclib formulation with 16 micrometer API particle size and dissolution level 2




Primary Outcome Measures :
  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 6 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: 6 days ]

Secondary Outcome Measures :
  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 6 days ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  2. Apparent Oral Clearance (CL/F) [ Time Frame: 6 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. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 2 Days ]
  4. Apparent Volume of Distribution (Vz/F) [ Time Frame: 6 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.

  5. Plasma Decay Half-Life (t1/2) [ Time Frame: 6 days ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.



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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 with no physical possibility of getting pregnant.
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

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 (eg, gastrectomy).
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) preceding the first dose of study medication.
  • Pregnant females; breastfeeding females; females with physical possibility of getting pregnant .

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): NCT02083640


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: NCT02083640     History of Changes
Other Study ID Numbers: A5481040
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: June 4, 2014
Last Verified: June 2014
Keywords provided by Pfizer:
healthy volunteer
bioavailability
palbociclib
formulation
Additional relevant MeSH terms:
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Palbociclib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action