Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-03-08 @ 11:01 PM
Study NCT ID:
NCT02388620
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2015-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Hepatic Function Impairment on the Pharmacokinetics of LEE011
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000589651', 'term': 'ribociclib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-16', 'studyFirstSubmitDate': '2015-03-02', 'studyFirstSubmitQcDate': '2015-03-09', 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Pharmacokinetic (PK) profile of a single oral dose of LEE011 in subjects with impaired hepatic function as compared to healthy subjects with normal hepatic function.', 'timeFrame': '14 days', 'description': 'PK profile includes the following parameters Tmax, Cmax, AUClast, AUCinf, T1/2, CL/F, Vz/F.'}], 'secondaryOutcomes': [{'measure': 'Frequency of adverse events (AEs)', 'timeFrame': 'From consent to 28 days post-dose', 'description': 'Safety profile of a single dose of LEE011 in healthy subjects and subjects with varying degrees of hepatic function includes changes observed in physical examination, changes in vital signs, changes in electrocardiograms (ECGs), abnormal laboratory results.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Normal Hepatic Function', 'Impaired Hepatic Function']}, 'referencesModule': {'references': [{'pmid': '33555033', 'type': 'DERIVED', 'citation': 'Samant TS, Yang S, Miller M, Ji Y. Pharmacokinetics of Ribociclib in Subjects With Hepatic Impairment. J Clin Pharmacol. 2021 Aug;61(8):1001-1009. doi: 10.1002/jcph.1825. Epub 2021 Mar 12.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=16928', 'label': 'Results for CLEE011A2109 can be found on the Novartis Clinical Trial Results Website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability of a single oral dose of LEE011 in subjects with varying degrees of impaired hepatic function (based on Child-Pugh classification) as compared to demographically-matched control subjects with normal hepatic function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll Subjects:\n\nMale or female (sterile or postmenopausal) subjects between 18-75 (both inclusive) years of age and healthy as determined by absence of clinically significant deviation from normal in medical history, physical examination, vital signs, electrocardiograms, and clinical laboratory determinations.\n\nSubjects must have a BMI between 18 kg/m2 and 36 kg/m2 and weight at least 50 kg and no more than 120 kg.\n\nOther than hepatic impairment, subjects must be in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, (except for additional inclusion criteria described below).\n\nSubjects in Child-Pugh A, B and C cohorts: Additional inclusion criteria\n\nChild-Pugh Clinical Assessment Score consistent with degree of hepatic impairment\n\nNo change in hepatic status at least one month prior to dosing (i.e. worsening of Child-Pugh score).\n\nExclusion Criteria:\n\nAll Subjects:\n\nSubject has received a liver transplant at any time in the past and is on immunosuppressant therapy.\n\nHistory or presence of impaired cardiac function\n\nAny surgical or medical condition that may significantly alter the absorption, distribution, metabolism or excretion of drugs\n\nAdministration of CYP3A4/5 inhibitors or inducers or CYP3A4 substrates with narrow therapeutic windows\n\nAdministration of medications that prolong the QT interval\n\nHistory of immunodeficiency diseases, including HIV, as confirmed by (HIV-1, HIV-2) test.\n\nParticipation in another clinical trial within 4 weeks prior to the study drug administration.\n\nSubjects with normal hepatic function:\n\nAdditional exclusion criteria A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.\n\nSubjects in Child-Pugh A, B and C cohorts:\n\nAdditional exclusion criteria\n\nClinical evidence of severe ascites (e.g. requiring regular tapping).\n\nBilirubin \\> 6 mg/dL'}, 'identificationModule': {'nctId': 'NCT02388620', 'briefTitle': 'Evaluation of Hepatic Function Impairment on the Pharmacokinetics of LEE011', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase I, Open Label, Multi-center, Parallel Cohort, Single Dose Study to Evaluate the Pharmacokinetics of LEE011 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function.', 'orgStudyIdInfo': {'id': 'CLEE011A2109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal Hepatic Function', 'description': 'Normal hepatic function; matched demography to hepatic impairment cohorts', 'interventionNames': ['Drug: LEE011']}, {'type': 'EXPERIMENTAL', 'label': 'Mild Hepatic Impairment', 'description': 'Child-Pugh Classification A (score 5-6)', 'interventionNames': ['Drug: LEE011']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Hepatic Impairment', 'description': 'Child-Pugh Classification B (score 7-9)', 'interventionNames': ['Drug: LEE011']}, {'type': 'EXPERIMENTAL', 'label': 'Severe Hepatic Impairment', 'description': 'Child-Pugh Classification C (score 10-15)', 'interventionNames': ['Drug: LEE011']}], 'interventions': [{'name': 'LEE011', 'type': 'DRUG', 'otherNames': ['Ribociclib'], 'description': '400 mg', 'armGroupLabels': ['Mild Hepatic Impairment', 'Moderate Hepatic Impairment', 'Normal Hepatic Function', 'Severe Hepatic Impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '33124', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}