Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-02-28 @ 12:41 AM
Study NCT ID:
NCT01626651
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2012-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C551803', 'term': 'ibrutinib'}, {'id': 'D007654', 'term': 'Ketoconazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-18', 'studyFirstSubmitDate': '2012-06-18', 'studyFirstSubmitQcDate': '2012-06-20', 'lastUpdatePostDateStruct': {'date': '2013-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ibrutinib plasma concentrations after administration on Day 1', 'timeFrame': 'over 72 hours after dosing on Day 1'}, {'measure': 'Ibrutinib plasma concentrations after administration on Day 7', 'timeFrame': 'over 72 hours after dosing on Day 7'}, {'measure': 'Metabolite PCI-45227 plasma concentrations after administration on Day 1', 'timeFrame': 'over 72 hours after dosing on Day 1'}, {'measure': 'Metabolite PCI-45227 plasma concentrations after administration on Day 7', 'timeFrame': 'over 72 hours after dosing on Day 7'}], 'secondaryOutcomes': [{'measure': 'Ibrutinib urine concentrations after administration on Day 1', 'timeFrame': 'over 72 hours after dosing on Day 1'}, {'measure': 'Ibrutinib urine concentrations after administration on Day 7', 'timeFrame': 'over 72 hours after dosing on Day 7'}, {'measure': 'Metabolite PCI-45227 urine concentrations after administration on Day 1', 'timeFrame': 'over 72 hours after dosing on Day 1'}, {'measure': 'Metabolite PCI-45227 urine concentrations after administration on Day 7', 'timeFrame': 'over 72 hours after dosing on Day 7'}, {'measure': 'Incidence of adverse events as a measure of safety and tolerability', 'timeFrame': 'Approximately 41 days'}]}, 'conditionsModule': {'keywords': ['Healthy', 'Ketoconazole', 'Ibrutinib'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the potential effects of ketoconazole on the pharmacokinetics of ibrutinib in healthy participants.', 'detailedDescription': 'This is a single-center, open-label (all people know the identity of the intervention), sequential design study in healthy men. All participants will receive ibrutinib on Day 1 and ibrutinib in combination with ketoconazole on Day 7. Food will be restricted from the evening before dosing until 4 hours after dosing on Days 1 and 7. Following an overnight fast, ketoconazole will be given on Days 4 to 6, 1 hour prior to ibrutinib dosing on Day 7, and again on Days 8 and 9. All ibrutinib and ketoconazole doses will be administered with water. The participants will leave the study center on Day 10.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) between 18 and 30 kg/m2, and body weight not less than 50 kg\n* Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic\n* Non-smoker\n* Must agree to use an adequate contraception method during the study and minimally 3 months after the last dose of ibrutinib, and to not donate sperm during the study and for 3 months after receiving the last dose of study drug\n* Signed an informed consent document\n\nExclusion Criteria:\n\n* History of or current clinically significant medical illness\n* Clinically significant abnormal physical examination, vital signs or electrocardiogram (ECG)\n* Clinically significant abnormal values for laboratorial tests\n* Use of any prescription or nonprescription medication, except for acetaminophen, within 3 days before the first dose of the study drug is schedule\n* History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 2 years'}, 'identificationModule': {'nctId': 'NCT01626651', 'briefTitle': 'A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'An Open-Label, Sequential Design Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CR100870'}, 'secondaryIdInfos': [{'id': 'PCI-32765CLL1002', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ibrutinib and Ketoconazole', 'interventionNames': ['Drug: Ibrutinib', 'Drug: Ketoconazole']}], 'interventions': [{'name': 'Ibrutinib', 'type': 'DRUG', 'description': 'A single oral dose of 120 mg ibrutinib (3 x 40 mg capsules) on Day 1, and 40 mg (1x 40 mg capsule) ibrutinib on Day 7.', 'armGroupLabels': ['Ibrutinib and Ketoconazole']}, {'name': 'Ketoconazole', 'type': 'DRUG', 'description': 'Ketoconazole (400 mg \\[2 x 200 mg\\] once daily) will be orally administered on Days 4, 5, 6, 7, 8 and 9.', 'armGroupLabels': ['Ibrutinib and Ketoconazole']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Neptune City', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.20011, 'lon': -74.02792}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}