Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT02103569
Status:
COMPLETED
Last Update Posted:
2014-08-15
First Post:
2014-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571889', 'term': 'asunaprevir'}, {'id': 'C587012', 'term': '8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamide'}, {'id': 'D004997', 'term': 'Ethinyl Estradiol'}, {'id': 'C020416', 'term': 'norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination'}], 'ancestors': [{'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': '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'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-13', 'studyFirstSubmitDate': '2014-04-01', 'studyFirstSubmitQcDate': '2014-04-01', 'lastUpdatePostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone', 'timeFrame': 'Day 21 to Day 49'}, {'measure': 'Maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone', 'timeFrame': 'Day 21 to Day 49'}], 'secondaryOutcomes': [{'measure': 'Dose-normalized area under the concentration versus time curve in 1 dosing interval (AUC (TAU)) of Ethinyl Estradiol and Norethindrone', 'timeFrame': 'Day 1 to Day 50'}, {'measure': 'Dose-normalized maximum observed plasma concentration (Cmax) of Ethinyl Estradiol and Norethindrone', 'timeFrame': 'Day 1 to Day 50'}, {'measure': 'Time of maximum observed plasma concentration (Tmax) of Ethinyl Estradiol and Norethindrone', 'timeFrame': 'Day 1 to Day 50'}, {'measure': 'Safety measured by occurrence of Adverse events (AEs), serious AEs and AEs leading to discontinuation', 'timeFrame': 'Day 1 to Day 50'}, {'measure': 'Safety measured by abnormalities in vital sign measurements', 'timeFrame': 'Day 1 to Day 50'}, {'measure': 'Safety measured by findings on Electrocardiogram (ECG) measurements and physical examinations', 'timeFrame': 'Day 1 to Day 50'}, {'measure': 'Safety measured by marked abnormalities in clinical laboratory test results', 'timeFrame': 'Day 1 to Day 50'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of the oral contraceptive agent.', 'detailedDescription': 'IND Number: 79,599 and 101,943\n\nOther: Phase 1 Clinical Pharmacology drug interaction study in healthy female subjects'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Healthy females within age of 18-40 years\n* Must be a Women of Childbearing potential\n* Must be on a stable regimen of oral contraceptive therapy for at least 3 consecutive months prior to study start\n\nExclusion Criteria:\n\n* Subjects must not have any significant acute or chronic medical illnesses or conditions precluding safe use of oral contraceptives\n* Prior exposure to DCV, ASV or BMS-791325 within 30 days of dosing on study day 1\n* Smoking within 6 months of study start'}, 'identificationModule': {'nctId': 'NCT02103569', 'briefTitle': 'Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Effect of a Combination of Daclatasvir, Asunaprevir, and BMS-791325 on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone Acetate in Healthy Female Subjects', 'orgStudyIdInfo': {'id': 'AI443-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325', 'description': 'Cycle 1- Low dose FDC of Norethindrone and Ethinyl Estradiol tablet orally on specified days\n\nCycle 2- High dose FDC of Norethindrone and Ethinyl Estradiol tablet orally on specified days and High dose FDC of Norethindrone and Ethinyl Estradiol + FDC of Daclatasvir, Asunaprevir and BMS-791325 + BMS-791325 tablets orally on specified days', 'interventionNames': ['Drug: FDC of Daclatasvir, Asunaprevir and BMS-791325', 'Drug: FDC of Norethindrone and Ethinyl Estradiol', 'Drug: BMS-791325']}], 'interventions': [{'name': 'FDC of Daclatasvir, Asunaprevir and BMS-791325', 'type': 'DRUG', 'armGroupLabels': ['Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325']}, {'name': 'FDC of Norethindrone and Ethinyl Estradiol', 'type': 'DRUG', 'otherNames': ['Loestrin®'], 'armGroupLabels': ['Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325']}, {'name': 'BMS-791325', 'type': 'DRUG', 'armGroupLabels': ['Arm 1: FDC of NE/EE + DCV 3DAA FDC + BMS-791325']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}