Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food

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NCT02097329

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Evidence or history of clinically significant diseases (hematological, renal,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric,
neurologic, or allergic disease).


- Use of tobacco or nicotine containing products within 3 months of screening.


- A positive urine drug screen.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food
Official Title  ICMJE A Phase 1, Open-Label, 3-Period Crossover Study Of The Effect Of An Antacid, A Proton Pump Inhibitor And An H2-Receptor Antagonist On Palbociclib (PD-0332991) Bioavailability Under Fed Conditions In Healthy Volunteers
Brief Summary To investigate the effect of acid reducing agents (an antacid and an H2-receptor antagonist and a proton pump inhibitor) on palbociclib bioavailability in the presence of food.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: palbociclib commercial free base
    125 mg oral capsule single dose
  • Drug: famotidine
    20 mg oral tablet 10 hours before and 2 hours after palbociclib
    Other Name: Pepcid
  • Drug: rabeprazole
    2 x 20 mg oral tablets daily for 6 days then on 7th day, 4 hours after palbociclib
    Other Name: Aciphex
  • Drug: antacid
    30 mL orally once (2h before palbociclib)
    Other Name: Mi-Acid Maximum Strength Liquid
  • Drug: antacid
    30 mL orally once (2h after palbociclib)
    Other Name: Mi-Acid Maximum Strength Liquid
Study Arms  ICMJE
  • Experimental: Cohort 1: Palbociclib under fed conditions
    Interventions:
    • Drug: palbociclib commercial free base
    • Drug: famotidine
    • Drug: rabeprazole
  • Experimental: Cohort 2: Palbociclib under fed conditions
    Interventions:
    • Drug: palbociclib commercial free base
    • Drug: antacid
    • Drug: antacid
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: June 17, 2014)		27
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2014)		28
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • 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 diseases (hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease).
  • Use of tobacco or nicotine containing products within 3 months of screening.
  • A positive urine drug screen.
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 NCT02097329
Other Study ID Numbers  ICMJE A5481038
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 CenterPfizer
PRS Account Pfizer
Verification Date June 2014

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