Ignite Creation Date:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-29 @ 11:13 AM
Study NCT ID:
NCT01702506
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2012-10-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007863', 'term': 'Lecithin Cholesterol Acyltransferase Deficiency'}], 'ancestors': [{'id': 'D052456', 'term': 'Hypoalphalipoproteinemias'}, {'id': 'D007009', 'term': 'Hypolipoproteinemias'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-16', 'studyFirstSubmitDate': '2012-10-04', 'studyFirstSubmitQcDate': '2012-10-04', 'lastUpdatePostDateStruct': {'date': '2013-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]', 'timeFrame': '2 weeks', 'description': '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'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '2 weeks', 'description': 'For dacomitinib and PF-05199265'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]', 'timeFrame': '2 weeks', 'description': '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'}, {'measure': 'Area under the Concentration-Time Curve (AUC)', 'timeFrame': '3 days', 'description': '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'}, {'measure': 'Apparent Oral Clearance (CL/F)', 'timeFrame': '2 weeks', 'description': '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'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': '2 weeks', 'description': 'For dacomitinib and PF-05199265'}, {'measure': 'Apparent Volume of Distribution (Vz/F)', 'timeFrame': '2 weeks', 'description': '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'}, {'measure': 'Plasma Decay Half-Life (t1/2)', 'timeFrame': '2 weeks', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. For dacomitinib'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dacomitinib', 'PF-00299804', 'fed', 'fasted', 'antacid', 'relative Bioavailability'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '26179237', 'type': 'DERIVED', 'citation': 'Ruiz-Garcia A, Masters JC, Mendes da Costa L, LaBadie RR, Liang Y, Ni G, Ellery CA, Boutros T, Goldberg Z, Bello CL. Effect of food or proton pump inhibitor treatment on the bioavailability of dacomitinib in healthy volunteers. J Clin Pharmacol. 2016 Feb;56(2):223-30. doi: 10.1002/jcph.588. Epub 2015 Oct 9.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7471015&StudyName=Evaluation%20Of%20The%20Potential%20Effect%20That%20The%20Administration%20Of%20Food%20Or%20Antacid%20Medication%20May%20Have%20In%20The%20Oral%20Absorption%20Of%20Dacomitini', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects including males between the ages of 18 and 55 years. Females of non childbearing potential .\n* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg (110 lbs).\n* An informed consent document signed and dated by the subject.\n\nExclusion Criteria:\n\n* Any condition possibly affecting drug absorption (eg, gastrectomy).\n* A positive urine drug screen.\n* 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.'}, 'identificationModule': {'nctId': 'NCT01702506', 'briefTitle': 'Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'A7471015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fasted', 'description': 'Dacomitinib administered under fasted conditions', 'interventionNames': ['Drug: dacomitinib fasted']}, {'type': 'EXPERIMENTAL', 'label': 'Fed', 'description': 'Dacomitinib administered under fed conditions', 'interventionNames': ['Drug: dacomitinib fed']}, {'type': 'EXPERIMENTAL', 'label': 'Antacid', 'description': 'Dacomitinib administered under antacid treatment', 'interventionNames': ['Drug: dacomitinib+antacid']}], 'interventions': [{'name': 'dacomitinib fasted', 'type': 'DRUG', 'description': 'Overnight fasted subjects will receive a single 45 mg dose of dacomitinib', 'armGroupLabels': ['Fasted']}, {'name': 'dacomitinib fed', 'type': 'DRUG', 'description': 'Subjects will receive a single 45 mg dose of dacomitinib with a high calorie high fat meal', 'armGroupLabels': ['Fed']}, {'name': 'dacomitinib+antacid', 'type': 'DRUG', 'description': 'Subjects will receive a single 45 mg dose of dacomitinib when there are treated with rabeprazole', 'armGroupLabels': ['Antacid']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}