protocolSection identificationModule nctId: NCT06354257, orgStudyIdInfo id: 220104, briefTitle: A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-05, primaryCompletionDateStruct date: 2024-10-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: GlaxoSmithKline, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to provide data showing if there are any effects of GSK3036656 on a combined oral contraceptive containing Ethinyl Estradiol (EE) and Levonorgestrel (LNG), which will help inform future studies on suitable contraceptive measures to be used., conditionsModule conditions: Tuberculosis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Fixed sequence, primaryPurpose: PREVENTION, maskingInfo masking: NONE, maskingDescription: Open-label, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: EE/LNG, interventions name: GSK3036656 Dose Level 1, interventions name: GSK3036656 Dose Level 2, outcomesModule primaryOutcomes measure: Area under the plasma drug concentration (AUC)-time curve from time zero to extrapolated to infinity (AUC[0-inf]) of EE after being administered with 14 days of GSK3036656 at DL 2, primaryOutcomes measure: Maximum observed concentration (Cmax) of EE after being administered with 14 days of GSK3036656 at DL 2, primaryOutcomes measure: AUC(0-inf) of LNG after being administered with 14 days of GSK3036656 at DL 2, primaryOutcomes measure: Cmax of LNG after being administered with 14 days of GSK3036656 at DL 2, secondaryOutcomes measure: AUC over the dosing interval (0-tau) of GSK3036656 after being administered with a single dose of EE/LNG, secondaryOutcomes measure: Cmax of GSK3036656 after being administered with a single dose of EE/LNG, secondaryOutcomes measure: Steady state assessment using trough plasma concentration (Ctau) of GSK3036656 after being administered with a single dose of EE/LNG, secondaryOutcomes measure: Tmax of GSK3036656 after being administered with a single dose of EE/LNG, secondaryOutcomes measure: AUC versus time curve (AUC[0-t]) of EE/LNG after being administered with a single dose of EE/LNG, secondaryOutcomes measure: AUC(0-t) of EE/LNG after being administered with 14 days of treatment with GSK3036656 at DL 2, secondaryOutcomes measure: Tmax of EE/LNG after being administered with a single dose of EE/LNG, secondaryOutcomes measure: Tmax of EE/LNG after being administered with 14 days of GSK3036656 DL 2, secondaryOutcomes measure: Apparent terminal half-life (t1/2) of EE and LNG after a single dose of EE/LNG, secondaryOutcomes measure: t1/2 of EE and LNG after a single dose of EE/LNG in combination with 14 days of treatment with GSK3036656 at DL 2, secondaryOutcomes measure: Number of participants with serious adverse events (SAEs), secondaryOutcomes measure: Number of participants with Grade 3 or higher severity adverse events (AEs), secondaryOutcomes measure: Number of participants with drug-related AEs, secondaryOutcomes measure: Number of participants with drug-related AEs following the administration of GSK3036656, secondaryOutcomes measure: Number of participants withdrawn from the treatment/study due to AEs, secondaryOutcomes measure: Percentage of participants with ECG values of Potential Clinical Importance (PCI), secondaryOutcomes measure: Percentage of participants with clinical chemistry laboratory values of PCI, secondaryOutcomes measure: Percentage of participants with haematology laboratory values of PCI, secondaryOutcomes measure: Percentage of participants with vital signs parameters of PCI, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: GSK Investigational Site, city: Madrid, zip: 28046, country: Spain, 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: Alberto Borobia Perez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False