- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01702506
Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804)
December 16, 2013 updated by: Pfizer
Phase 1 Three Period Crossover Study To Evaluate The Effect Of Food And Antacids On The Pharmacokinetics, Safety & Tolerability Of PF-299,804 In Healthy Volunteers Who Have Received PF-299,804
Evaluation of the potential effect that the administration of food or antacid medication may have in the oral absorption of dacomitinib relative to the administration of dacomitinib in absence of food or antacid medication
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
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
-
-
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Bruxelles, Belgium, B-1070
- Pfizer Investigational Site
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-
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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy subjects including males between the ages of 18 and 55 years. Females of non childbearing potential .
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject.
Exclusion Criteria:
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or the appropriate time based on the elimination characteristics of the study medication.
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: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fasted
Dacomitinib administered under fasted conditions
|
Overnight fasted subjects will receive a single 45 mg dose of dacomitinib
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Experimental: Fed
Dacomitinib administered under fed conditions
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Subjects will receive a single 45 mg dose of dacomitinib with a high calorie high fat meal
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Experimental: Antacid
Dacomitinib administered under antacid treatment
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Subjects will receive a single 45 mg dose of dacomitinib when there are treated with rabeprazole
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time Frame: 2 weeks
|
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).
For dacomitinib and PF-05199265
|
2 weeks
|
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 2 weeks
|
For dacomitinib and PF-05199265
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Time Frame: 2 weeks
|
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).For dacomitinib and PF-05199265
|
2 weeks
|
Area under the Concentration-Time Curve (AUC)
Time Frame: 3 days
|
AUC is a measure of the serum concentration of the drug over time.
It is used to characterize drug absorption.
For dacomitinib and PF-05199265
|
3 days
|
Apparent Oral Clearance (CL/F)
Time Frame: 2 weeks
|
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.
For dacomitinib
|
2 weeks
|
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 2 weeks
|
For dacomitinib and PF-05199265
|
2 weeks
|
Apparent Volume of Distribution (Vz/F)
Time Frame: 2 weeks
|
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.
For dacomitinib
|
2 weeks
|
Plasma Decay Half-Life (t1/2)
Time Frame: 2 weeks
|
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
For dacomitinib
|
2 weeks
|
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
October 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
October 4, 2012
First Submitted That Met QC Criteria
October 4, 2012
First Posted (Estimate)
October 8, 2012
Study Record Updates
Last Update Posted (Estimate)
December 18, 2013
Last Update Submitted That Met QC Criteria
December 16, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A7471015
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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