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Trial record 1 of 1 for:    NCT02311946
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A Pilot Study To Investigate The Effect Of Concurrent Antacid Administration On The Bioavailability Of Six Experimental Formulations Of Palbociclib

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ClinicalTrials.gov Identifier: NCT02311946
Recruitment Status : Completed
First Posted : December 9, 2014
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE December 4, 2014
First Posted Date  ICMJE December 9, 2014
Last Update Posted Date May 28, 2015
Study Start Date  ICMJE January 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2014)
  • AUCinf [ Time Frame: Pre-dose to 120 hours post-dose ]
    Area under the concentration-time curve from time zero to infinity.
  • Cmax [ Time Frame: Pre-dose to 120 hours post-dose ]
    Maximum observed plasma concentration
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2014)
  • AUClast [ Time Frame: Pre-dose to 120 hours post-dose ]
    Area under the concentration-time curve from time zero to the time of the last quantifiable concentration.
  • CL/F [ Time Frame: Pre-dose to 120 hours post-dose ]
    Apparent oral clearance from plasma
  • Tmax [ Time Frame: Pre-dose to 120 hours post-dose ]
    Time of the maximum observed concentration post-dose.
  • Vz/F [ Time Frame: Pre-dose to 120 hours post-dose ]
    Apparent volume of distribution
  • t1/2 [ Time Frame: Pre-dose to 120 hours post-dose ]
    Terminal phase half-life
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study To Investigate The Effect Of Concurrent Antacid Administration On The Bioavailability Of Six Experimental Formulations Of Palbociclib
Official Title  ICMJE A Phase 1, Open-Label Fixed-Sequence 2-Period Crossover Study Of Palbociclib (pd-0332991) In Healthy Volunteers To Estimate The Effect Of Antacid Treatment On The Bioavailability Of A 125 Mg Single Dose Of Six Experimental Formulations Of Palbociclib Relative To Palbociclib Administration Alone Under Fasted Conditions
Brief Summary This study will investigate whether concurrent administration of rabeprazole, an antacid known as a proton pump inhibitor, alters the absorption of the drug palbociclib when given as one of six experimental formulations.
Detailed Description This will be a 6 cohort study investigating one experimental formulation of palbociclib in each of the six cohorts of 10 healthy subjects. Each cohort will receive two treatments in a fixed-sequence. In Period 1, all subjects will receive a single 125mg dose of palbociclib alone and undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose. In Period 2, all subjects will receive daily 40mg doses of Rabeprazole for 7 consecutive days, and approximately 4 hours after the Day 7 rabeprazole dose each subject will receive a single 125mg dose of palbociclib. Subjects will undergo serial pharmacokinetic blood sampling up to 120 hours post-dose.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Palbociclib Alone
    In Period 1 of each Cohort, a single 125 mg dose of palbociclib will be administered alone in a fasted state, and subjects will undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose.
    Other Name: Palbociclib, PD-0332991
  • Drug: Palbociclib + Rabeprazole
    In Period 2 of each Cohort, subjects will receive daily 40 mg oral doses of the proton pump inhibitor rabeprazole on 7 consecutive days. Approximately 4 hours after the last rabeprazole dose a single 125 mg dose of palbociclib will be administered alone in a fasted state, and subjects will undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose.
    Other Name: Palbociclib, PD-0332991, Rabeprazole, Aciphex, Proton Pump Inhibitor, PPI
Study Arms  ICMJE
  • Experimental: Cohort 1
    Cohort 1 will receive a 125 mg round yellow palbociclib tablet containing succinic acid
    Interventions:
    • Drug: Palbociclib Alone
    • Drug: Palbociclib + Rabeprazole
  • Experimental: Cohort 2
    Cohort 2 will receive a 125 mg oval yellow palbociclib spray-dried dispersion tablet containing HMPC E3
    Interventions:
    • Drug: Palbociclib Alone
    • Drug: Palbociclib + Rabeprazole
  • Experimental: Cohort 3
    Cohort 3 will receive a 125 mg oval yellow palbociclib spray-dried dispersion tablet with HMPC E3 and succinic acid.
    Interventions:
    • Drug: Palbociclib Alone
    • Drug: Palbociclib + Rabeprazole
  • Experimental: Cohort 4
    Cohort 4 will receive a 125 mg oval white/yellow palbociclib bilayer tablet with tartaric and succinic acid.
    Interventions:
    • Drug: Palbociclib Alone
    • Drug: Palbociclib + Rabeprazole
  • Experimental: Cohort 5
    Cohort 5 will receive a 125 mg oval yellow palbociclib fluid bed granulation tablet with succinic acid.
    Interventions:
    • Drug: Palbociclib Alone
    • Drug: Palbociclib + Rabeprazole
  • Experimental: Cohort 6
    Cohort 6 will receive a 125 mg palbociclib oral solution
    Interventions:
    • Drug: Palbociclib Alone
    • Drug: Palbociclib + Rabeprazole
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: December 8, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy Male or Female of non-childbearing potential,
  • Having a body weight >50 kg
  • Having a bopy mass index (BMI) between 17.5 and 30.5 kg/m2.

Exclusion Criteria:

  • Any condition possibly affecting drug absorption (eg, gastrectomy)
  • A positive urine drug or cotinine test
  • A known history of hypersensitivity to palbociclib
  • A supine systolic blood pressure >140 mmHg, or a QTc >450 msec.
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 NCT02311946
Other Study ID Numbers  ICMJE A5481041
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 May 2015

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