Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT03249402
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2017-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Healthy Female Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019304', 'term': 'Ethinyl Estradiol-Norgestrel Combination'}, {'id': 'C000655226', 'term': 'seltorexant'}], 'ancestors': [{'id': 'D004997', 'term': 'Ethinyl Estradiol'}, {'id': 'D009651', 'term': 'Norpregnatrienes'}, {'id': 'D009650', 'term': 'Norpregnanes'}, {'id': 'D009654', 'term': 'Norsteroids'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D009644', 'term': 'Norgestrel'}, {'id': 'D009652', 'term': 'Norpregnenes'}, {'id': 'D042782', 'term': 'Estrogenic Steroids, Alkylated'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2017-08-11', 'studyFirstSubmitQcDate': '2017-08-11', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) in Cycle 1', 'timeFrame': 'Cycle 1: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, 24h, 28h, 36h, 48h and 72h Postdose', 'description': 'The Cmax is the maximum observed plasma concentration.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) in Cycle 2', 'timeFrame': 'Cycle 2: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, 24h, 28h, 36h, 48h and 72h Postdose', 'description': 'The Cmax is the maximum observed plasma concentration.'}, {'measure': 'Trough Plasma Concentration (Ctrough) in Cycle 1', 'timeFrame': 'Cycle1: Predose (Day 21)', 'description': 'The (Ctrough) is the observed plasma concentration just prior to the beginning of a dosing interval.'}, {'measure': 'Trough Plasma Concentration (Ctrough) in Cycle 2', 'timeFrame': 'Cycle 2: Predose (Day 21)', 'description': 'The (Ctrough) is the observed plasma concentration just prior to the beginning of a dosing interval.'}, {'measure': 'Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) at Cycle 1', 'timeFrame': 'Cycle 1: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, Day 22: 24h Postdose', 'description': 'The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.'}, {'measure': 'Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) at Cycle 2', 'timeFrame': 'Cycle 2: Predose (Day 21), 30 minute (min), 1 hour (h), 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 20h, Day 22: 24h Postdose', 'description': 'The AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': 'Up to 87 Days', 'description': 'An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of multiple 40 milligram (mg) doses of JNJ-42847922 on the steady state pharmacokinetics (PK) of multiple doses of a combination oral contraceptive (OC) containing ethinyl estradiol (EE) and levonorgestrel (LN) in healthy female adult partcipants.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be female of childbearing potential (women with tubal ligation are not accepted)\n* Have a body weight equal to or over 45 kilogram (kg) and a body mass index (BMI) 23 within the range of 18 to 30 kilogram / square meter (kg/m\\^2) inclusive\n* Have a systolic blood pressure between 90 and 140 millimeter of mercury (mmHg), inclusive, and diastolic blood pressure no higher than 90 mmHg\n* Agree not to donate eggs (ova, oocytes) during the study and for at least 90 days after receiving the last dose of study drug\n* Have a negative serum pregnancy test at screening and a negative predose urine pregnancy test on Day1 and Day 21 of Cycle 1 and Cycle 2\n\nExclusion Criteria:\n\n* Participant has a past history of heart arrhythmias (extrasystolic, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)\n* Participant is currently pregnant or planning to become pregnant or lactating (from screening through at least 8 weeks after receiving the last dose of study drug)\n* Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody positive, or other clinically active liver disease, or tests positive for HBsAg or hepatitis C virus antibody at screening.\n* Participant has a history of or present allergy to the oral contraceptive (OC) or JNJ-42847922, or drugs of these classes, or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation\n* Participant has a history of alcohol/drug abuse or dependence within 12 months of the study: history of regular alcohol consumption averaging greater than (\\>) 14 drinks/week for women within 6 months of screening'}, 'identificationModule': {'nctId': 'NCT03249402', 'briefTitle': 'A Study to Evaluate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Healthy Female Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen-Cilag International NV'}, 'officialTitle': 'An Open-label Drug-drug Interaction Study in Healthy Female Adult Subjects to Investigate the Effect of Multiple Oral Doses of JNJ-42847922 on the Steady-state Pharmacokinetics of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel', 'orgStudyIdInfo': {'id': 'CR108351'}, 'secondaryIdInfos': [{'id': '2016-004725-16', 'type': 'EUDRACT_NUMBER'}, {'id': '42847922MDD1003', 'type': 'OTHER', 'domain': 'Janssen-Cilag International NV'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Contraceptive Tablet + JNJ-42847922', 'description': 'All participants will receive one oral contraceptive (OC) tablet containing ethinyl estradiol (EE) 0.03 milligram (mg) and levonorgestrel (LN) 0.15 mg once daily on Days 1 to 21 for both cycle 1 and cycle 2. In addition, in cycle 2, participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21. Participants will not be given OC tablet on Days 22 to 28 during cycle 1 and cycle 2 (tablet-free period).', 'interventionNames': ['Drug: Ethinyl Estradiol + Levonorgestrel', 'Drug: JNJ-42847922']}], 'interventions': [{'name': 'Ethinyl Estradiol + Levonorgestrel', 'type': 'DRUG', 'otherNames': ['Microgynon 30'], 'description': 'Participants will receive one OC tablet containing EE 0.03 mg and LN 0.15 mg once daily on Days 1 to 21 in cycles 1 and 2.', 'armGroupLabels': ['Oral Contraceptive Tablet + JNJ-42847922']}, {'name': 'JNJ-42847922', 'type': 'DRUG', 'description': 'Participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21 in cycle 2.', 'armGroupLabels': ['Oral Contraceptive Tablet + JNJ-42847922']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2060', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'SGS Life Science Services', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'overallOfficials': [{'name': 'Janssen-Cilag International NV Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen-Cilag International NV'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen-Cilag International NV', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}