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
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Apr 2014
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2014
CompletedFirst Posted
Study publicly available on registry
March 27, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJune 19, 2014
June 1, 2014
2 months
March 24, 2014
June 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
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).
6 days
Maximum Observed Plasma Concentration (Cmax)
6 days
Secondary Outcomes (5)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
6 days
Apparent Oral Clearance (CL/F)
6 days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
6 days
Apparent Volume of Distribution (Vz/F)
6 days
Plasma Decay Half-Life (t1/2)
6 days
Study Arms (2)
Cohort 1: Palbociclib under fed conditions
EXPERIMENTALCohort 2: Palbociclib under fed conditions
EXPERIMENTALInterventions
125 mg oral capsule single dose
20 mg oral tablet 10 hours before and 2 hours after palbociclib
2 x 20 mg oral tablets daily for 6 days then on 7th day, 4 hours after palbociclib
30 mL orally once (2h before palbociclib)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2014
First Posted
March 27, 2014
Study Start
April 1, 2014
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
June 19, 2014
Record last verified: 2014-06