Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-27 @ 1:53 PM
Study NCT ID:
NCT00382668
Status:
COMPLETED
Last Update Posted:
2011-04-14
First Post:
2006-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Dasatinib to See How Liver Impaired and Healthy Subjects Process and React to the Study Drug
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069439', 'term': 'Dasatinib'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-13', 'studyFirstSubmitDate': '2006-09-26', 'studyFirstSubmitQcDate': '2006-09-28', 'lastUpdatePostDateStruct': {'date': '2011-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hepatically impaired'], 'conditions': ['Liver Diseases']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate how a person with liver impairment processes and reacts to the study drug. Information about any side effects that may occur will also be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male and Female Subjects with hepatic insufficiency conforming to Child-Pugh classification B\n\nMale and Female Subjects with hepatic insufficiency conforming to Child-Pugh classification C\n\nHealthy Control subjects in good health', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria - All subjects:\n\n* Male and females ≥18 years old\n* Women must be of non-childbearing potential\n* Adequate hematologic and renal function\n* BMI 18-35 kg/m2\n\nInclusion Criteria - Liver Impaired subjects:\n\n* Subjects must have stable liver impairment diagnosed with standard classification - Child Pugh\n\nExclusion Criteria - All subjects:\n\n* Inability to swallow or absorb oral medication\n* Uncontrolled medical disorder or infection\n* Use of CYP3A4 inhibitors/inducers or drugs with risk of Torsades de Pointes\n* Uncontrolled or Significant cardiovascular disease\n* Any significant bleeding disorder\n* Female subjects of childbearing potential\n* Male subjects unwilling to use an effective method of contraception throughout the conduct of the study and for 2 months thereafter'}, 'identificationModule': {'nctId': 'NCT00382668', 'briefTitle': 'A Study of Dasatinib to See How Liver Impaired and Healthy Subjects Process and React to the Study Drug', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Single-Dose Pharmacokinetics of Dasatinib in Subjects With Hepatic Impairment Compared to Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'CA180-051'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A', 'interventionNames': ['Drug: Dasatinib']}, {'label': 'B', 'interventionNames': ['Drug: Dasatinib']}, {'label': 'C', 'interventionNames': ['Drug: Dasatinib']}], 'interventions': [{'name': 'Dasatinib', 'type': 'DRUG', 'otherNames': ['Sprycel'], 'description': 'Tablets, Oral, 50 mg, once daily, for one day', 'armGroupLabels': ['A']}, {'name': 'Dasatinib', 'type': 'DRUG', 'otherNames': ['Sprycel'], 'description': 'Tablets, Oral, 20 mg, once daily for one day', 'armGroupLabels': ['B']}, {'name': 'Dasatinib', 'type': 'DRUG', 'otherNames': ['Sprycel'], 'description': 'Tablets, Oral, 70 mg, once daily for one day', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University Of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33025', 'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'facility': 'Comprehensive Phase One', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'New Orleans Center For Clinical Research', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}