Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-31 @ 10:01 PM
Study NCT ID:
NCT06250205
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013607', 'term': 'Tablets'}, {'id': 'C035144', 'term': 'drospirenone'}, {'id': 'D004997', 'term': 'Ethinyl Estradiol'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Open-label, multiple-dose, fixed sequence, drug-drug interaction study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-14', 'studyFirstSubmitDate': '2024-02-01', 'studyFirstSubmitQcDate': '2024-02-01', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of COC', 'timeFrame': 'Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)', 'description': 'Plasma Cmax concentration of COC with and without Obicetrapib'}, {'measure': 'Area under the plasma concentration-time (AUC0-τ) curve for COC with and without coadministration with Obicetrapib', 'timeFrame': 'Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)', 'description': 'Plasma AUC0-τ for COC with and without coadministration of Obicetrapib'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DDI, drug-drug interaction, combined oral contraceptive'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'A study to evaluate the impact of Obicetrapib on the PK levels of Drospirenone and Ethinyl Estradiol (COC) in 30 adult female, healthy volunteers.', 'detailedDescription': 'This is an interventional, drug-drug interaction study to evaluate the effect of daily doses of Obicetrapib tablets on the pharmacokinetics of a combined oral contraceptive (COC), Drospirenone and Ethinyl Estradiol.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-pregnant, non-lactating, non-tobacco-, non-nicotine-using female, 18-35 years of age, inclusive, who is a candidate for hormonal contraception (as determined by the Investigator).\n* Subject has a BMI of 18.5-29.9 kg/m², inclusive. BMI will be calculated using Novum Pharmaceutical Research Services Standard Operating Procedures.\n* If the subject is currently using a hormonal method of contraception, the subject is willing and agrees to stop using her hormonal contraceptive throughout the duration of the study and is prepared to abstain from sexual intercourse or use a reliable non-hormonal method of contraception, as outlined below\n\nExclusion Criteria:\n\n* Male\n* Have given birth or been pregnant within 3 months before initial dosing, or is currently pregnant, lactating or likely to become pregnant during the study.\n* History of Hypertension, or seated blood pressure for a minimum of 5 minutes \\>140mmHg systolic, or \\> 80 mmHg, diastolic at screening'}, 'identificationModule': {'nctId': 'NCT06250205', 'briefTitle': 'Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib', 'organization': {'class': 'INDUSTRY', 'fullName': 'NewAmsterdam Pharma'}, 'officialTitle': 'A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics of Drospirenone and Ethinyl Estradiol in Healthy Adult Female Subjects', 'orgStudyIdInfo': {'id': 'TA-8995-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment B+C: Obicetrapib + Drospirenone/Ethinyl Estradiol (COC)', 'description': 'Obicetrapib 10 mg tablets and Drospirenone (3mg)/Ethinyl Estradiol (0.02mg) tablet', 'interventionNames': ['Drug: Obicetrapib', 'Drug: Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B: Obicetrapib', 'description': 'Obicetrapib 10 mg tablets (daily)', 'interventionNames': ['Drug: Obicetrapib']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C: Drospirenone/Ethinyl Estradiol tablets (COC)', 'description': 'Drospirenone (3mg)/Ethinyl Estradiol tablets (0.02mg) tablet', 'interventionNames': ['Drug: Drospirenone / Ethinyl Estradiol (COC)']}], 'interventions': [{'name': 'Obicetrapib', 'type': 'DRUG', 'otherNames': ['10 mg tablet'], 'description': 'oral administration', 'armGroupLabels': ['Treatment B+C: Obicetrapib + Drospirenone/Ethinyl Estradiol (COC)', 'Treatment B: Obicetrapib']}, {'name': 'Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)', 'type': 'DRUG', 'otherNames': ['tablets'], 'description': 'oral administration', 'armGroupLabels': ['Treatment B+C: Obicetrapib + Drospirenone/Ethinyl Estradiol (COC)']}, {'name': 'Drospirenone / Ethinyl Estradiol (COC)', 'type': 'DRUG', 'otherNames': ['tablets'], 'description': 'oral administration', 'armGroupLabels': ['Treatment C: Drospirenone/Ethinyl Estradiol tablets (COC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89121', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'NOVUM', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}], 'overallOfficials': [{'name': 'Kent A Swaine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novum Pharmaceutical Research Services, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NewAmsterdam Pharma', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novum', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}