Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-02-22 @ 7:22 PM
Study NCT ID:
NCT02837692
Status:
COMPLETED
Last Update Posted:
2017-10-30
First Post:
2016-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Effects of Age and Gender on the Pharmacokinetics of JNJ-42847922 in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000655226', 'term': 'seltorexant'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-26', 'studyFirstSubmitDate': '2016-06-02', 'studyFirstSubmitQcDate': '2016-07-15', 'lastUpdatePostDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) of JNJ-42847922', 'timeFrame': 'Day 1 (Pre-dose) up to Day 3', 'description': 'The Cmax is the maximum observed plasma concentration.'}, {'measure': 'Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]) of JNJ-42847922', 'timeFrame': 'Day 1 (Pre-dose) up to Day 3', 'description': 'The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.'}, {'measure': 'Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of JNJ-42847922', 'timeFrame': 'Day 1 (Pre-dose) up to Day 3', 'description': 'The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events and serious adverse events as a measure of safety and tolerability', 'timeFrame': 'Baseline up to 10 days after last dose of study drug (Day 14)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the pharmacokinetics of single-dose evening administration of JNJ-42847922 in elderly non-Asian adults compared with weight- and gender-matched young healthy non-Asian adults and to assess the pharmacokinetics of single-dose evening administration of JNJ-42847922 in healthy Japanese adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* In Group A: For each cohort, 10 elderly non-Asian adults greater than or equal to (\\>=)65 years old, with at least 2 participants \\>=70 years and \\<75 years old, at least 2 participants \\>=75 years old, with 5 participants of each sex; In Group B: For each cohort, 10 young healthy non-Asian adults 18 to 45 years old, inclusive, matched to elderly participants in the same cohort by gender and body weight (plus \\[+\\] or minus \\[-\\]5 kilogram \\[kg\\]); In Group C: For each cohort, 10 healthy Japanese adults 20 to 60 years old, inclusive, who have resided outside of Japan for less than or equal to (\\<=)10 years, have parents and maternal and paternal grandparents who are Japanese, who primarily consume a Japanese diet, with 5 participants of each sex\n* Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study\n* Group B and Group C: If a woman, must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test on Day 1 of the treatment period\n* Group B and Group C: If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 3 months after the last study drug administration\n* If a man who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (eg, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug\n* Has body mass index (BMI) (weight kilogram\\[kg\\]/height\\^2 meter\\[m\\]\\^2) between 18 and 30 kg/m2 (inclusive) with a body weight not less than 50 kg for non-Asian subjects (Group A and Group B) and not less than 45 kg for Japanese subjects (Group C)\n\nExclusion Criteria:\n\n* Received a known inhibitor of cytochrome P450 3A4 (CYP3A4) 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\n* Consumption of products containing grapefruit or Seville oranges within 28 days before the first dose of the study drug is scheduled\n* Received an experimental drug or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the first dose of the study drug is scheduled\n* Unable to swallow solid, oral dosage forms whole with the aid of water (participants may not chew, divide, dissolve, or crush the study drug)\n* Positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies"}, 'identificationModule': {'nctId': 'NCT02837692', 'briefTitle': 'A Study to Assess the Effects of Age and Gender on the Pharmacokinetics of JNJ-42847922 in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'An Open-Label Single Dose Study to Assess the Effects of Age and Gender on the Pharmacokinetics of JNJ-42847922 in Healthy Adults', 'orgStudyIdInfo': {'id': 'CR108176'}, 'secondaryIdInfos': [{'id': '42847922EDI1014', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Participants assigned to Cohort 1 group A (elderly non-Asian), group B (young healthy non-Asian) and group C (healthy Japanese) will receive JNJ-42847922 10 mg, 3 hours after completing dinner.', 'interventionNames': ['Drug: JNJ-42847922 10 milligram (mg)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Participants assigned to Cohort 2 group A, group B and group C will receive JNJ-42847922 20 mg, 3 hours after completing dinner.', 'interventionNames': ['Drug: JNJ-42847922 20 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Participants assigned to Cohort 3 group A and group C will receive JNJ-42847922 40 mg, 3 hours after completing dinner. Participants in group B will receive JNJ-42847922 40 mg, 3 hours after completing dinner in Period 1, followed by at least 7 days washout period, further followed by JNJ-42847922 40 mg, immediately after completing dinner.', 'interventionNames': ['Drug: JNJ-42847922 40 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': 'Participants assigned to Cohort 4 group B will receive JNJ-42847922 60 or 80 mg, 3 hours after completing dinner.', 'interventionNames': ['Drug: JNJ-42847922 60 or 80 mg']}], 'interventions': [{'name': 'JNJ-42847922 10 milligram (mg)', 'type': 'DRUG', 'description': 'JNJ-42847922 will be administered as single tablet of 10 mg, orally, once on Day 1.', 'armGroupLabels': ['Cohort 1']}, {'name': 'JNJ-42847922 20 mg', 'type': 'DRUG', 'description': 'JNJ-42847922 will be administered as 1 tablet of 20 mg, orally, once on Day 1.', 'armGroupLabels': ['Cohort 2']}, {'name': 'JNJ-42847922 40 mg', 'type': 'DRUG', 'description': 'JNJ-42847922 will be administered as 2 tablets of 20 mg, orally, once on Day 1.', 'armGroupLabels': ['Cohort 3']}, {'name': 'JNJ-42847922 60 or 80 mg', 'type': 'DRUG', 'description': 'JNJ-42847922 will be administered as 3 or 4 tablets of 20 mg, orally, once on Day 1. Dose to be determined from Cohort 3, Period 1.', 'armGroupLabels': ['Cohort 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cypress', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}, {'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], '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'}}}}