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

• ClinicalTrials.gov Identifier: NCT02097329
• Recruitment Status: Completed
• First Posted: March 27, 2014
• Last Update Posted: June 19, 2014
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: March 24, 2014
• First Posted Date: March 27, 2014
• Last Update Posted Date: June 19, 2014
• Study Start Date: April 2014
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 24, 2014)

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 6 days ]
  AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
• Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 6 days ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 24, 2014)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 6 days ]
  Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
• Apparent Oral Clearance (CL/F) [ Time Frame: 6 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: 6 days ]
• Apparent Volume of Distribution (Vz/F) [ Time Frame: 6 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: 6 days ]
  Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 17, 2014): 27
• Original Estimated Enrollment (submitted: March 24, 2014): 28
• Actual Study Completion Date: June 2014
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02097329
• Other Study ID Numbers: A5481038
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: June 2014