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Trial record 1 of 1 for:    NCT01844323
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A Study In Healthy Volunteers To Estimate The Effect Of The Active Ingredient Particle Size And Percentage Of The Excipients Used To Formulate The Capsules In The Dissolution Rate Of The Formulations In The Gastrointestinal Tract

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ClinicalTrials.gov Identifier: NCT01844323
Recruitment Status : Completed
First Posted : May 1, 2013
Last Update Posted : August 28, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 16, 2013
First Posted Date  ICMJE May 1, 2013
Last Update Posted Date August 28, 2013
Study Start Date  ICMJE June 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
  • Area under the Concentration-Time Curve (AUC) from time zero extrapolate to infinite time [ Time Frame: 7 days ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: 7 days ]
    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 2 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2013)
  • Area under the Concentration-Time Curve (AUC) from time zero extrapolate to infinite time [ Time Frame: 7 days ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: 7 days ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 2 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
  • 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)
  • Area under the Concentration-Time Curve (AUC) from 0 to 72 [ Time Frame: 3 days ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
  • 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.
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 2 days ]
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2013)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 7 days ]
  • Area under the Concentration-Time Curve (AUC) from 0 to 72 [ Time Frame: 3 days ]
  • Apparent Oral Clearance (CL/F) [ Time Frame: 7 days ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 2 days ]
  • Apparent Volume of Distribution (Vz/F) [ Time Frame: 7 days ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 7 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study In Healthy Volunteers To Estimate The Effect Of The Active Ingredient Particle Size And Percentage Of The Excipients Used To Formulate The Capsules In The Dissolution Rate Of The Formulations In The Gastrointestinal Tract
Official Title  ICMJE A Phase 1, Open-Label 4 Sequence 4 Period Crossover Study In Healthy Volunteers To Estimate The Effect Of Active Pharmaceutical Ingredient Particle Size And Lubrication On The Bioavailability Of A Single 125 Mg Dose Of Palbociclib (PD-0332991) Administered Under Fasted Conditions
Brief Summary The particle size of the active ingredient may impact dissolution rate in the gastro intestinal tract and hence the amount of drug available for absorption. Similarly, differences in the percentage of the excipients used in the formulated capsules may affect dissolution rate. The purpose of this study is to estimate the effect that particle size and percentage of excipients could have in drug absorption, which will improve the manufacturing process of the formulated capsules.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Other: Palbociclib Formulation Reference
    Single 45 mg dose; Dosage form is capsule taken orally.
  • Other: Palbociclib Formulation Test
    Single 45 mg dose; Dosage form is capsule taken orally.
Study Arms  ICMJE
  • Active Comparator: Treatment A
    treatment A, reference, 20 micron palbociclib and lubrication level 1
    Intervention: Other: Palbociclib Formulation Reference
  • Active Comparator: Treatment B
    treatment B, test, 50 micron palbociclib and lubrication level 1
    Intervention: Other: Palbociclib Formulation Test
  • Active Comparator: Treatment C
    treatment C, test, 20 micron palbociclib and lubrication level 2
    Intervention: Other: Palbociclib Formulation Test
  • Active Comparator: Treatment D
    treatment D, test, 20 micron palbociclib and lubrication level 3
    Intervention: Other: Palbociclib Formulation Test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2013)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 .
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01844323
Other Study ID Numbers  ICMJE A5481022
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP