Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-04-08 @ 10:43 PM
Study NCT ID:
NCT02857868
Status:
COMPLETED
Last Update Posted:
2020-12-08
First Post:
2016-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000621806', 'term': 'asciminib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-06', 'studyFirstSubmitDate': '2016-04-27', 'studyFirstSubmitQcDate': '2016-08-02', 'lastUpdatePostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Pharmacokinetics (PK): Cmax', 'timeFrame': 'at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose', 'description': 'To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects'}, {'measure': 'Primary Pharmacokinetics (PK): AUClast', 'timeFrame': 'at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose', 'description': 'To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects'}, {'measure': 'Primary Pharmacokinetics (PK): AUCinf', 'timeFrame': 'at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose', 'description': 'To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects'}, {'measure': 'Secondary Pharmacokinetics (PK): Tmax', 'timeFrame': 'at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose', 'description': 'To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects'}, {'measure': 'Secondary Pharmacokinetics (PK): T 1/2', 'timeFrame': 'at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose', 'description': 'To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects'}, {'measure': 'Secondary Pharmacokinetics (PK): CL/F', 'timeFrame': 'at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose', 'description': 'To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects'}, {'measure': 'Secondary Pharmacokinetics (PK): Vz/F', 'timeFrame': 'at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose', 'description': 'To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects'}], 'secondaryOutcomes': [{'measure': 'Percentage of plasma protein binding as expressed by unbound fraction in plasma', 'timeFrame': '2 hours post-dose', 'description': 'To evaluate ABL001 plasma protein binding'}, {'measure': 'ABL001 pharmacokinetic parameter - Cmax - based on unbound fraction in plasma', 'timeFrame': '2 hours post-dose', 'description': 'Unbound fraction I plasma includes but is not limited to unbound Cmax (Cmax)'}, {'measure': 'ABL001 pharmacokinetic parameter - AUClast - based on unbound fraction in plasma', 'timeFrame': '2 hours post-dose', 'description': 'Unbound fraction I plasma includes but is not limited to unbound AUClast (AUClast)'}, {'measure': 'ABL001 pharmacokinetic parameter - AUCinf - based on unbound fraction in plasma', 'timeFrame': '2 hours post-dose', 'description': 'Unbound fraction I plasma includes but is not limited to unbound AUCinf (AUCinf)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatic Impairment', 'ABL001', 'Child-Pugh', 'healthy subjects with normal hepatic function'], 'conditions': ['Hepatic Impairment']}, 'referencesModule': {'references': [{'pmid': '34115385', 'type': 'DERIVED', 'citation': 'Hoch M, Sato M, Zack J, Quinlan M, Sengupta T, Allepuz A, Aimone P, Hourcade-Potelleret F. Pharmacokinetics of Asciminib in Individuals With Hepatic or Renal Impairment. J Clin Pharmacol. 2021 Nov;61(11):1454-1465. doi: 10.1002/jcph.1926. Epub 2021 Jul 16.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17159', 'label': 'Results for CABL001A2103 can be found on the Novartis Clinical Trial Results Website'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child-Pugh classification) on the pharmacokinetics (PK) of ABL001 after a single oral dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion criteria:\n\n* Body mass index of 18-36 kg/m2, with body weight 50 kg and no more than 120 kg\n* Vital signs (after at least 3 minutes rest in the supine position) within the following ranges (inclusive):\n\n * Oral body temperature between 35.0 °C - 37.5 °C (95.0-99.5°F)\n * Systolic BP ≥90 mmHg and ≤140 mmHg\n * Diastolic BP ≥60 mmHg and ≤90 mmHg for healthy subjects and 50-100 mmHg for subjects with impaired hepatic function (groups 2-4)\n * Pulse Rate: ≥50 and ≤90 bpm for healthy subjects (group 1) and ≥50 and ≤100 bpm for subjects with impaired hepatic function (groups 2-4)\n* Healthy subjects with no clinically significant abnormalities as determined by past medical history, physical examination, vital signs, ECG, and clinical laboratory test\n* Subjects with Child-Pugh Clinical Assessment Score as calculated per the Child-Pugh classification\n\nKey Exclusion Criteria:\n\n* Presence of clinically significant ECG abnormalities or a family history or presence of prolonged QT-interval syndrome\n* History of cardiac disease\n* Sexually active males must use a condom during intercourse while taking the drug and for 7 days after stopping\n* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs\n* Administration of strong or moderate CYP3A4 inhibitors or inducers (including St John's wort) within 14 days prior to dosing\n\nOther protocol-defined inclusion/exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT02857868', 'briefTitle': 'A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase I, Open-label, Multi-center, Single-dose Study to Evaluate the Pharmacokinetics of ABL001 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function', 'orgStudyIdInfo': {'id': 'CABL001A2103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABL001', 'interventionNames': ['Drug: ABL001']}], 'interventions': [{'name': 'ABL001', 'type': 'DRUG', 'armGroupLabels': ['ABL001']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami / Clinical Research Services, Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'DaVita Clinical Research', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}