Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-31 @ 7:00 PM
Study NCT ID:
NCT06380205
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Drug Interaction Between Povorcitinib and the Oral Contraceptive Levonorgestrel/Ethinyl Estradiol in Healthy Adult Females
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019304', 'term': 'Ethinyl Estradiol-Norgestrel Combination'}], '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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-01', 'studyFirstSubmitDate': '2024-04-03', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levonorgestrel (LNG) concentration in plasma', 'timeFrame': 'Up to Day 21', 'description': 'LNG concentration in plasma.'}, {'measure': 'Ethinyl estradiol (EE) concentration in plasma', 'timeFrame': 'Up to Day 21', 'description': 'EE concentration in plasma.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to Day 32', 'description': 'Defined as any adverse event, either reported for the first time or the worsening of a pre-existing event, occurring after first dose of study treatment.'}, {'measure': 'Additional LNG/EE PK parameters in plasma', 'timeFrame': 'Up to Day 21', 'description': 'Additional LNG/EE PK parameters in plasma.'}, {'measure': 'Povorcitinib concentration in plasma', 'timeFrame': 'Up to Day 21', 'description': 'Povorcitinib concentration in plasma.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['INCB054707'], 'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the drug interaction between povorcitinib and the oral contraceptive levonorgestrel/ethinyl estradiol in healthy adult females.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ability to comprehend and willingness to sign a written ICF for the study.\n* Females aged 18 to 60 years, inclusive, at the time of signing the ICF.\n* Body mass index between 18.0 and 30.5 kg/m2, inclusive.\n* No clinically significant findings in screening evaluations (eg, clinical, laboratory, and ECG evaluations).\n* Ability to swallow and retain oral medication.\n\nExclusion Criteria:\n\n* History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months before screening.\n* Presence or history of a malabsorption syndrome (eg, Crohn's disease or chronic pancreatitis) that could affect drug absorption.\n* Current or recent (within 3 months before screening) clinically significant gastrointestinal disease (eg, gallbladder disease) or surgery (including cholecystectomy; excluding appendectomy) that could affect the absorption of study treatment.\n* History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease (eg, deep vein thrombosis), pulmonary embolism, or uncontrolled hypertension (ie, blood pressure \\> 140/90 mmHg at screening, confirmed by repeat testing).\n* Positive test for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization for or immunity due to infection with HBV may be included at the discretion of the investigator.\n* History of tobacco- or nicotine-containing product-use within 1 month before screening.\n* Pregnant, breastfeeding, or planning to conceive during the study.\n\nOther protocol-defined Inclusion/Exclusion Criteria may apply."}, 'identificationModule': {'nctId': 'NCT06380205', 'briefTitle': 'A Study to Evaluate the Drug Interaction Between Povorcitinib and the Oral Contraceptive Levonorgestrel/Ethinyl Estradiol in Healthy Adult Females', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'A Phase 1, Open-Label Study to Evaluate the Drug Interaction Between Povorcitinib and the Oral Contraceptive Levonorgestrel/Ethinyl Estradiol in Healthy Adult Females', 'orgStudyIdInfo': {'id': 'INCB54707-111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Povorcitinib + levonorgestrel (LNG)/ethinyl estradiol (EE)', 'description': 'Povorcitinib and LNG/EE will be administered at the protocol defined doses.', 'interventionNames': ['Drug: Povorcitinib', 'Drug: Levonorgestrel/Ethinyl estradiol']}], 'interventions': [{'name': 'Povorcitinib', 'type': 'DRUG', 'otherNames': ['INCB054707'], 'description': 'Povorcitinib will be administered at protocol defined dose.', 'armGroupLabels': ['Povorcitinib + levonorgestrel (LNG)/ethinyl estradiol (EE)']}, {'name': 'Levonorgestrel/Ethinyl estradiol', 'type': 'DRUG', 'description': 'Levonorgestrel/Ethinyl estradiol will be administered at protocol defined dose.', 'armGroupLabels': ['Povorcitinib + levonorgestrel (LNG)/ethinyl estradiol (EE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Celerion Clinical Research Unit', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}], 'overallOfficials': [{'name': 'Incyte Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}