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A Pilot Study To Investigate The Effect Of Concurrent Antacid Administration On The Bioavailability Of Six Experimental Formulations Of Palbociclib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Palbociclib Alone Drug: Palbociclib + Rabeprazole Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : January 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
Cohort 1 will receive a 125 mg round yellow palbociclib tablet containing succinic acid
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

Experimental: Cohort 2
Cohort 2 will receive a 125 mg oval yellow palbociclib spray-dried dispersion tablet containing HMPC E3
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

Experimental: Cohort 3
Cohort 3 will receive a 125 mg oval yellow palbociclib spray-dried dispersion tablet with HMPC E3 and succinic acid.
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

Experimental: Cohort 4
Cohort 4 will receive a 125 mg oval white/yellow palbociclib bilayer tablet with tartaric and succinic acid.
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

Experimental: Cohort 5
Cohort 5 will receive a 125 mg oval yellow palbociclib fluid bed granulation tablet with succinic acid.
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

Experimental: Cohort 6
Cohort 6 will receive a 125 mg palbociclib oral solution
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




Primary Outcome Measures :
  1. AUCinf [ Time Frame: Pre-dose to 120 hours post-dose ]
    Area under the concentration-time curve from time zero to infinity.

  2. Cmax [ Time Frame: Pre-dose to 120 hours post-dose ]
    Maximum observed plasma concentration


Secondary Outcome Measures :
  1. 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.

  2. CL/F [ Time Frame: Pre-dose to 120 hours post-dose ]
    Apparent oral clearance from plasma

  3. Tmax [ Time Frame: Pre-dose to 120 hours post-dose ]
    Time of the maximum observed concentration post-dose.

  4. Vz/F [ Time Frame: Pre-dose to 120 hours post-dose ]
    Apparent volume of distribution

  5. t1/2 [ Time Frame: Pre-dose to 120 hours post-dose ]
    Terminal phase half-life



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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.

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): NCT02311946


Locations
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United States, Florida
MRA Clinical Research - Phase 1
Miami, Florida, United States, 33143
Miami Research Associates, LLC
South Miami, Florida, United States, 33143
MRA Clinical Research, LLC
South Miami, Florida, United States, 33143
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02311946    
Other Study ID Numbers: A5481041
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by Pfizer:
Palbociclib, Rabeprazole, Proton Pump Inhibitor, Drug Interaction Study, DDI
Additional relevant MeSH terms:
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Palbociclib
Rabeprazole
Proton Pump Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents