Completed
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
What is being tested
dacomitinib fasted
+ dacomitinib fed
+ dacomitinib+antacid
Drug
Who is being recruted
Hypolipoproteinemias+8
+ Lipid Metabolism, Inborn Errors
+ Metabolic Diseases
From 18 to 55 Years
+6 Eligibility Criteria
How is the trial designed
Basic Science Study
Phase 1
Interventional
Study Start: October 2012
Summary
Principal SponsorPfizer
Last updated: December 18, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.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
Principal SponsorPfizer
Last updated: December 18, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
HypolipoproteinemiasLipid Metabolism, Inborn ErrorsMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesGenetic Diseases, InbornDyslipidemiasLipid Metabolism DisordersHypoalphalipoproteinemiasLecithin Cholesterol Acyltransferase Deficiency
Criteria
3 inclusion criteria required to participate
An informed consent document signed and dated by the subject
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight > 50 kg (110 lbs)
Healthy subjects including males between the ages of 18 and 55 years. Females of non childbearing potential
3 exclusion criteria prevent from participating
A positive urine drug screen
Any condition possibly affecting drug absorption (eg, gastrectomy)
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
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalDacomitinib administered under fasted conditions
Group II
ExperimentalDacomitinib administered under fed conditions
Group III
ExperimentalDacomitinib administered under antacid treatment
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center