protocolSection identificationModule nctId: NCT06310616, orgStudyIdInfo id: 219888, briefTitle: A Study to Investigate the Potential Drug-Drug Interaction Between VH4524184 and Oral Contraceptive (Loestrin) in Healthy Adult Female Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-06, primaryCompletionDateStruct date: 2024-05-28, completionDateStruct date: 2024-05-28, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: ViiV Healthcare, class: INDUSTRY, descriptionModule briefSummary: This study aims to assess any impact of VH4524184 on the pharmacokinetic (PK) profile of an ethinyl estradiol (EE) and norethindrone acetate (NEA) containing oral contraceptive (OC) administered to healthy adult female participants., conditionsModule conditions: HIV Infections, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: VH4524184, interventions name: Loestrin, outcomesModule primaryOutcomes measure: Area under the concentration-time curve (AUC) from time zero (pre-dose) to the end of the dosing interval at steady state (AUC0-Tau, ss) of EE and NEA without coadministration with VH4524184, primaryOutcomes measure: AUC0-Tau, ss of EE and NEA with coadministration with VH4524184, primaryOutcomes measure: Maximum plasma concentration (Cmax) for EE and NEA without coadministration with VH4524184, primaryOutcomes measure: Cmax for EE and NEA with coadministration with VH4524184, secondaryOutcomes measure: Number of participants with adverse events (AEs) and severity of AEs, secondaryOutcomes measure: Number of participants with AEs leading to discontinuation of study intervention, secondaryOutcomes measure: Change from baseline of liver panel laboratory parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ASP) (International units per liter), secondaryOutcomes measure: Change from baseline of liver panel laboratory parameters: Total bilirubin, Direct bilirubin (Micromoles per liter [umol/L]), secondaryOutcomes measure: Change from baseline of liver panel laboratory parameters: International normalized ratio (INR) (Ratio), secondaryOutcomes measure: Number of participants with maximum toxicity grade increase from baseline of liver panel laboratory parameters: ALT, AST, alkaline phosphatase, total bilirubin, Direct bilirubin, and INR, secondaryOutcomes measure: Maximum plasma concentration at steady state (Cmax,ss) for VH4524184, secondaryOutcomes measure: Time to maximum concentration at steady state (Tmax, ss) during dosing interval for VH4524184, secondaryOutcomes measure: Area under the concentration-time curve from time zero(pre-dose) to the end of the dosing interval at steady state (AUC0-Tau, ss) for VH4524184, secondaryOutcomes measure: Trough concentration prior to the next dose (Ctrough) for VH4524184, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: GSK Investigational Site, status: RECRUITING, city: San Antonio, state: Texas, zip: 78209, country: United States, contacts name: US GSK Clinical Trials Call Center, role: CONTACT, phone: 877-379-3718, email: GSKClinicalSupportHD@gsk.com, contacts name: EU GSK Clinical Trials Call Centre, role: CONTACT, phone: +44 (0) 20 8990 4466, email: GSKClinicalSupportHD@gsk.com, contacts name: Chinonye Chika Ogbonnaya-Odor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, hasResults: False