Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-11 @ 1:30 PM
Study NCT ID:
NCT02192294
Status:
COMPLETED
Last Update Posted:
2014-10-31
First Post:
2014-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Absolute Bioavailability Of Bosutinib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C471992', 'term': 'bosutinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-30', 'studyFirstSubmitDate': '2014-07-14', 'studyFirstSubmitQcDate': '2014-07-14', 'lastUpdatePostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the Concentration-Time Curve (AUC)', 'timeFrame': '96 hours', 'description': 'AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '96 hours', 'description': 'Maximum Observed Plasma Concentration'}, {'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'timeFrame': '96 hours', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': '96 hours', 'description': 'Time to Reach Maximum Observed Plasma Concentration'}, {'measure': 'Plasma Decay Half-Life (t1/2)', 'timeFrame': '96 hours', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Systemic Clearance (CL)', 'timeFrame': '96 hours', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body.'}, {'measure': 'Volume of Distribution at Steady State (Vss)', 'timeFrame': '96 hours', '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 blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bosutinib', 'absolute bioavailability'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '29058816', 'type': 'DERIVED', 'citation': 'Hsyu PH, Pignataro DS, Matschke K. Absolute Bioavailability of Bosutinib in Healthy Subjects From an Open-Label, Randomized, 2-Period Crossover Study. Clin Pharmacol Drug Dev. 2018 May;7(4):373-381. doi: 10.1002/cpdd.396. Epub 2017 Oct 23.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1871044&StudyName=Absolute%20Bioavailability%20Of%20Bosutinib', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label, randomized, single-dose, one-cohort, two-sequence, two-period crossover study in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female subjects (of non-childbearing potential).\n* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.\n* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, accept placement of indwelling catheter for infusion and other study procedures.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).\n* A positive urine drug screen for cocaine, tetrahydrocannabinol (THC), opiates/opioids, benzodiazepines and amphetamines.'}, 'identificationModule': {'nctId': 'NCT02192294', 'briefTitle': 'Absolute Bioavailability Of Bosutinib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Open-label, Randomized, 2-period Crossover Study To Evaluate Absolute Bioavailability Of Bosutinib In Healthy Subjects', 'orgStudyIdInfo': {'id': 'B1871044'}, 'secondaryIdInfos': [{'id': '2014-001405-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bosutinib', 'interventionNames': ['Drug: Oral Bosutinib', 'Drug: Intravenous infusion of bosutinib']}], 'interventions': [{'name': 'Oral Bosutinib', 'type': 'DRUG', 'description': 'a single dose of 500 mg oral bosutinib', 'armGroupLabels': ['Bosutinib']}, {'name': 'Intravenous infusion of bosutinib', 'type': 'DRUG', 'description': 'a single dose of 120 mg of bosutinib intravenous infusion (1 hour)', 'armGroupLabels': ['Bosutinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Ruddington Fields', 'state': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Clinical'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}