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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
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.

NCT02097329
Pfizer
Completed
Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food

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Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food
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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
June 2014
June 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02097329
A5481038
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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