nctId: NCT06354257 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 overallStatus: NOT_YET_RECRUITING date: 2024-04-05 date: 2024-10-30 date: 2024-10-30 date: 2024-04-09 date: 2024-04-09 name: GlaxoSmithKline class: INDUSTRY 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. conditions: Tuberculosis studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Fixed sequence primaryPurpose: PREVENTION masking: NONE maskingDescription: Open-label count: 25 type: ESTIMATED name: EE/LNG name: GSK3036656 Dose Level 1 name: GSK3036656 Dose Level 2 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 measure: Maximum observed concentration (Cmax) of EE after being administered with 14 days of GSK3036656 at DL 2 measure: AUC(0-inf) of LNG after being administered with 14 days of GSK3036656 at DL 2 measure: Cmax of LNG after being administered with 14 days of GSK3036656 at DL 2 measure: AUC over the dosing interval (0-tau) of GSK3036656 after being administered with a single dose of EE/LNG measure: Cmax of GSK3036656 after being administered with a single dose of EE/LNG measure: Steady state assessment using trough plasma concentration (Ctau) of GSK3036656 after being administered with a single dose of EE/LNG measure: Tmax of GSK3036656 after being administered with a single dose of EE/LNG measure: AUC versus time curve (AUC[0-t]) of EE/LNG after being administered with a single dose of EE/LNG measure: AUC(0-t) of EE/LNG after being administered with 14 days of treatment with GSK3036656 at DL 2 measure: Tmax of EE/LNG after being administered with a single dose of EE/LNG measure: Tmax of EE/LNG after being administered with 14 days of GSK3036656 DL 2 measure: Apparent terminal half-life (t1/2) of EE and LNG after a single dose of EE/LNG 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 measure: Number of participants with serious adverse events (SAEs) measure: Number of participants with Grade 3 or higher severity adverse events (AEs) measure: Number of participants with drug-related AEs measure: Number of participants with drug-related AEs following the administration of GSK3036656 measure: Number of participants withdrawn from the treatment/study due to AEs measure: Percentage of participants with ECG values of Potential Clinical Importance (PCI) measure: Percentage of participants with clinical chemistry laboratory values of PCI measure: Percentage of participants with haematology laboratory values of PCI measure: Percentage of participants with vital signs parameters of PCI sex: FEMALE minimumAge: 18 Years maximumAge: 65 Years stdAges: ADULT stdAges: OLDER_ADULT facility: GSK Investigational Site city: Madrid zip: 28046 country: Spain name: US GSK Clinical Trials Call Center role: CONTACT phone: 877-379-3718 email: GSKClinicalSupportHD@gsk.com name: EU GSK Clinical Trials Call Centre role: CONTACT phone: +44 (0) 20 8990 4466 email: GSKClinicalSupportHD@gsk.com name: Alberto Borobia Perez role: PRINCIPAL_INVESTIGATOR lat: 40.4165 lon: -3.70256 hasResults: False