Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-02-25 @ 12:55 AM
Study NCT ID:
NCT02661893
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2016-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Drug Interaction Study in Healthy Participants to Assess the Effect of Rifampin on the Pharmacokinetics of JNJ-42847922
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000655226', 'term': 'seltorexant'}, {'id': 'D012293', 'term': 'Rifampin'}], 'ancestors': [{'id': 'D012294', 'term': 'Rifamycins'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D047029', 'term': 'Lactams, Macrocyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2016-01-05', 'studyFirstSubmitQcDate': '2016-01-19', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by maximum plasma concentration (Cmax) on Day 1', 'timeFrame': 'Day 1', 'description': 'Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.'}, {'measure': 'Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by maximum plasma concentration (Cmax) on Day 5', 'timeFrame': 'Day 5', 'description': 'Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.'}, {'measure': 'Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by maximum plasma concentration (Cmax) on Day 12', 'timeFrame': 'Day 12', 'description': 'Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.'}, {'measure': 'Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by Area Under the Plasma Concentration-Time Curve (AUC) on Day 1', 'timeFrame': 'Day 1', 'description': 'Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.'}, {'measure': 'Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by Area Under the Plasma Concentration-Time Curve (AUC) on Day 5', 'timeFrame': 'Day 5', 'description': 'Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.'}, {'measure': 'Pharmacokinetics of JNJ-42847922 and metabolites M12 and M16 as assessed by Area Under the Plasma Concentration-Time Curve (AUC) on Day 12', 'timeFrame': 'Day 12', 'description': 'Blood samples will be collected after dosing of JNJ-42847922 on each occasion to assess the pharmacokinetics of JNJ-42847922 and metabolites M12, M16 with and without rifampin.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'up to Day 44', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy', 'JNJ-42847922', 'Rifampin', 'Pharmacokinetics'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of single- and multiple-dose of rifampin on the single-dose pharmacokinetics of JNJ-42847922 after oral administration to healthy male and female participants.', 'detailedDescription': "This is an open-label, fixed-sequence, single-center, multiple-dose study in 14 healthy adults. All participants will receive a single oral dose of 40 milligram (mg) JNJ-42847922 on 3 separate occasions: Day 1 (JNJ-42847922 alone), Day 5 (JNJ-42847922 with a single dose of rifampin), and Day 12 (JNJ-42847922 in combination with steady-state rifampin). A daily dose of 600 mg (2 \\* 300 mg) rifampin will be administered from Day 5 through Day 12. Following JNJ-42847922 dosing, serial blood samples will be collected over 48 hours for the evaluation of plasma concentrations of JNJ-42847922 and its metabolites. Participants' safety will be monitored throughout the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and women of non-child-bearing potential between 18 and 60 years of age, inclusive; body mass index (BMI) between 18 and 30 kilogram (kg)/meter\\^2, inclusive, and body weight of not less than 50 kg who are nonsmokers (current and for past 60 days)\n\nExclusion Criteria:\n\n* History of or current clinically significant medical illness\n* Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis\n* Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG)\n* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, within 14 days before the first dose of the study drug is scheduled until completion of the study\n* Received a known inhibitor of cytochrome P450 (CYP) 3A4 or CYP2C9 activity within 28 days or a period less than 5 times the drugs half-life; whichever is longer, before the first dose of the study drug is scheduled'}, 'identificationModule': {'nctId': 'NCT02661893', 'briefTitle': 'A Drug Interaction Study in Healthy Participants to Assess the Effect of Rifampin on the Pharmacokinetics of JNJ-42847922', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'An Open-Label Drug Interaction Study to Assess the Pharmacokinetics of JNJ-42847922 When Administered Alone and in Combination With Rifampin in Healthy Male and Female Subjects', 'orgStudyIdInfo': {'id': 'CR108077'}, 'secondaryIdInfos': [{'id': '42847922EDI1009', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JNJ-42847922 and Rifampin', 'description': 'A single oral dose of 40 milligram (mg) (=2\\*20 mg) dose of JNJ-42847922 on Day 1; A single oral dose of 40 mg (=2\\*20 mg) dose of JNJ-42847922 dosed with one oral dose of rifampin 600 mg (2\\*300 mg) on Day 5; A single oral dose of 40 mg (=2\\*20 mg) dose of JNJ-42847922 dosed on Day 12, following once daily dosing of rifampin with an oral dose of rifampin 600 mg (2\\*300 mg) on Days 5-12.', 'interventionNames': ['Drug: JNJ-42847922', 'Drug: Rifampin']}], 'interventions': [{'name': 'JNJ-42847922', 'type': 'DRUG', 'description': 'A single oral dose of 40 milligram (mg) (=2\\*20 mg) dose of JNJ42847922 on Day 1, Day 5 and Day 12.', 'armGroupLabels': ['JNJ-42847922 and Rifampin']}, {'name': 'Rifampin', 'type': 'DRUG', 'description': 'Oral dose of rifampin 600 mg (2\\*300 mg) on Day 5 and once daily dosing of rifampin with an oral dose of rifampin 600 mg (2\\*300 mg) on Days 5 to 12.', 'armGroupLabels': ['JNJ-42847922 and Rifampin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], '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'}}}}