- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02097329
Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food
June 17, 2014 updated by: Pfizer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1: Palbociclib under fed conditions
|
125 mg oral capsule single dose
20 mg oral tablet 10 hours before and 2 hours after palbociclib
Other Names:
2 x 20 mg oral tablets daily for 6 days then on 7th day, 4 hours after palbociclib
Other Names:
|
Experimental: Cohort 2: Palbociclib under fed conditions
|
125 mg oral capsule single dose
30 mL orally once (2h before palbociclib)
Other Names:
30 mL orally once (2h after palbociclib)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 6 days
|
6 days
|
|
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).
|
6 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
6 days
|
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.
|
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.
|
6 days
|
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.
|
6 days
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 6 days
|
6 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
March 24, 2014
First Submitted That Met QC Criteria
March 24, 2014
First Posted (Estimate)
March 27, 2014
Study Record Updates
Last Update Posted (Estimate)
June 19, 2014
Last Update Submitted That Met QC Criteria
June 17, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Gastrointestinal Agents
- Protective Agents
- Protein Kinase Inhibitors
- Adjuvants, Immunologic
- Proton Pump Inhibitors
- Antioxidants
- Histamine Antagonists
- Histamine Agents
- Histamine H2 Antagonists
- Palbociclib
- Rabeprazole
- TEMPO
- Magnesium Hydroxide
- Famotidine
- Antacids
- Aluminum Hydroxide
- Aluminum hydroxide, magnesium hydroxide, simethicone drug combination
- Anti-Ulcer Agents
Other Study ID Numbers
- A5481038
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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