Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-03-10 @ 8:36 PM
Study NCT ID:
NCT03465059
Status:
COMPLETED
Last Update Posted:
2020-04-24
First Post:
2018-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629551', 'term': 'zanubrutinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-22', 'studyFirstSubmitDate': '2018-03-07', 'studyFirstSubmitQcDate': '2018-03-13', 'lastUpdatePostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentration of Zanubrutinib (BGB-3111) to evaluate protocol specified PK parameters', 'timeFrame': 'Days 1, 2 & 3', 'description': 'Plasma concentration of Zanubrutinib (BGB-3111) to evaluate Area Under the Plasma Concentration-Time Curve (AUC) of Zanubrutinib'}, {'measure': 'Plasma concentration of Zanubrutinib (BGB-3111) to evaluate protocol specified PK parameters', 'timeFrame': 'Days 1, 2 & 3', 'description': 'Plasma concentration of Zanubrutinib (BGB-3111) to evaluate Maximum Observed Plasma Concentration (Cmax) of Zanubrutinib'}], 'secondaryOutcomes': [{'measure': 'Treatment-Emergent Adverse Events (AE)', 'timeFrame': 'up to Day 17', 'description': 'Percentage of Participants with Treatment-Emergent Adverse Events (AE)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BGB-3111', 'Zanubrutinib', 'pharmacokinetics', 'healthy subjects', 'hepatic impairment'], 'conditions': ['Hepatic Insufficiency & Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '32031037', 'type': 'RESULT', 'citation': 'Ou YC, Preston RA, Marbury TC, Tang Z, Novotny W, Tawashi M, Li TK, Sahasranaman S. A phase 1, open-label, single-dose study of the pharmacokinetics of zanubrutinib in subjects with varying degrees of hepatic impairment. Leuk Lymphoma. 2020 Jun;61(6):1355-1363. doi: 10.1080/10428194.2020.1719097. Epub 2020 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the safety and pharmacokinetics of zanubrutinib in subjects with impaired liver function in comparison with healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and/or female subjects in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening.\n* Subjects must have a body mass index (BMI) between 18 and 40 kg/m2 to participate at screening.\n* Female subject must be of non-childbearing potential, i.e. surgically sterile at least 6 months prior to screening with supportive clinical documentation OR post-menopausal must have no regular menstrual bleeding for at least 12 months prior to inclusion. Menopause will be confirmed by a plasma FSH level of \\>40 IU/L\n* Male subjects must agree to practice 2 highly effective methods of birth control at least one method must be barrier technique.\n\nAdditional Inclusion Criteria for Healthy Subjects Only:\n\n* In good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening; subjects without diseases/conditions\n* Matched with a hepatic impaired patient (mild, moderate or severe, as applicable) using the following criteria: sex, age ±10 years and body mass index (BMI)± 10 kilograms\n\nAdditional Inclusion Criteria for Hepatic Impaired Subjects Only:\n\n* History of cirrhosis with supportive documentation (ultrasonography, computed tomography scan, liver biopsy, magnetic resonance imaging, clinical laboratory tests results or physical signs consistent with a clinical diagnosis of liver cirrhosis.\n* Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment.\n* Blood pressure of 90 to 155 mmHg (systolic) and 50 to 100 mmHg (diastolic).\n* Otherwise considered healthy in general as determined by physical examination findings and laboratory assessments within normal limits.\n\nExclusion Criteria:\n\n* Subjects with a clinically relevant history or presence of any clinically significant disease.\n* History of drug or alcohol abuse within the 12 months prior to dosing.\n* A positive human immunodeficiency virus (HIV) Type 1 or 2 test result at screening.\n* History of blood donation of 500 mL or more of blood within 2 months prior to screening\n* A positive tuberculosis test result.\n\nAdditional Exclusion Criteria for Hepatic Impaired Subjects Only:\n\n* Received a liver transplant\n* Acute or exacerbating hepatitis\n* Active Stage 3 or 4 hepatic encephalopathy\n* Previously diagnosed with hepatocellular carcinoma, or a history of cholestatic liver disease or biliary sepsis within the past 2 years.\n* Additional Exclusion Criteria for Healthy Subjects Only: A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.\n* History of any clinically significant chronic and/or active hepatic disease.'}, 'identificationModule': {'nctId': 'NCT03465059', 'briefTitle': 'Safety and Pharmacokinetics of Zanubrutinib (BGB-3111) in Healthy Subjects and Those With Impaired Liver Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'BeiGene'}, 'officialTitle': 'A Phase 1, Open-label, Single-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Zanubrutinib (BGB-3111) in Subjects With Varying Degrees of Hepatic Impairment', 'orgStudyIdInfo': {'id': 'BGB-3111-107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal Hepatic Function', 'description': 'Participants with normal hepatic function will be administered a single oral dose of Zanubrutinib (80 mg).', 'interventionNames': ['Drug: Zanubrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Mild Hepatic Impairment', 'description': 'Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) will be administered a single dose of Zanubrutinib (80 mg).', 'interventionNames': ['Drug: Zanubrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Hepatic Impairment', 'description': 'Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) will be administered a single dose of Zanubrutinib (80 mg).', 'interventionNames': ['Drug: Zanubrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Severe Hepatic Impairment', 'description': 'Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) will be administered a single dose of Zanubrutinib (80 mg).', 'interventionNames': ['Drug: Zanubrutinib']}], 'interventions': [{'name': 'Zanubrutinib', 'type': 'DRUG', 'description': 'A single oral dose of 80 mg Zanubrutinib will be administered.', 'armGroupLabels': ['Mild Hepatic Impairment', 'Moderate Hepatic Impairment', 'Normal Hepatic Function', 'Severe Hepatic Impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33124', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', '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}}], 'overallOfficials': [{'name': 'William Novotny, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'BeiGene'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BeiGene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}