[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659410":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":11,"studyPopulation":11,"armGroups":30,"interventions":44,"overallOfficials":60,"centralContacts":64,"locations":11,"responsibleParty":73,"collaborators":11,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":11,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":11,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":101,"whyStopped":11,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":11},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Maximum observed plasma concentration (Cmax)",null,"Up to 72 hours",{"measure":14,"description":11,"timeFrame":12},"Area under the plasma concentration-time curve from time zero to 72 hours post-dose (AUC [0-72 hours])",[16,19,21],{"measure":17,"description":11,"timeFrame":18},"Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) by severity","Up to 47 days",{"measure":20,"description":11,"timeFrame":18},"Number of participants with clinically significant changes in clinical laboratory parameters, physical examinations, Electrocardiogram (ECG) and vital signs",{"measure":22,"description":11,"timeFrame":12},"Time to maximum observed plasma drug concentration (Tmax)",{"allocation":24,"interventionModel":25,"interventionModelDescription":11,"primaryPurpose":26,"observationalModel":11,"timePerspective":11,"maskingInfo":27},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":28,"maskingDescription":29,"whoMasked":11},"NONE","This is an open-label study.",[31,36,40],{"label":32,"type":33,"description":11,"interventionNames":34},"Participants receiving velzatinib","EXPERIMENTAL",[35],"Drug: Velzatinib",{"label":37,"type":33,"description":11,"interventionNames":38},"Participants receiving omeprazole + velzatinib",[35,39],"Drug: Omeprazole",{"label":41,"type":33,"description":11,"interventionNames":42},"Participants receiving velzatinib + cyclosporine",[35,43],"Drug: Cyclosporine",[45,52,56],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"DRUG","Velzatinib","Velzatinib will be administered.",[37,32,41],[51],"GSK6042981\u002FIDRX-42",{"type":46,"name":53,"description":54,"armGroupLabels":55,"otherNames":11},"Cyclosporine","Cyclosporine will be administered.",[41],{"type":46,"name":57,"description":58,"armGroupLabels":59,"otherNames":11},"Omeprazole","Omeprazole will be administered.",[37],[61],{"name":62,"affiliation":5,"role":63},"GSK Clinical Trials","STUDY_DIRECTOR",[65,70],{"name":66,"role":67,"phone":68,"phoneExt":11,"email":69},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":71,"role":67,"phone":72,"phoneExt":11,"email":69},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",{"type":74,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659410","phase-1-a-study-to-investigate-the-effect-of-omeprazole-and-cyclosporine-on-velzatinib-in-healthy-participants-100659410",false,"NCT07862114","A Study to Investigate the Effect of Omeprazole and Cyclosporine on Velzatinib in Healthy Participants","A Phase 1 Non-Randomized, Open-Label, Parallel-Group Study to Investigate the Effects of Coadministration of the Proton Pump Inhibitor Omeprazole or the P-gp\u002FBCRP Inhibitor Cyclosporine on the Pharmacokinetics, Safety, and Tolerability of Velzatinib in Healthy Participants","Inclusion Criteria:\n\n* Is 18 to 60 years of age, inclusive, at the time of signing the Informed Consent Form (ICF).\n* Healthy as determined by investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, vital sign measurements, and cardiac monitoring.\n* Has a body mass index (BMI) from 18.0 to less than (\\\u003C) 30.0 kilograms per square meter (kg\u002Fm\\^2).\n\nExclusion Criteria:\n\n* Has a history or evidence of clinically significant hematologic, dermatologic, neurologic, pulmonary, immunologic or atopic (except seasonal allergies), or endocrine disease, or psychiatric disorder (such as psychosis, delusions, or schizophrenia), or other abnormality, that may impact the ability of the participant to participate or potentially confound the study results, or that, in the investigator's opinion, makes the participant unsuitable for the study.\n* Presence (within 6 months) or history of significant liver or gastrointestinal (GI) disease that would be expected to influence the absorption of drugs (i.e., a history of malabsorption, any surgical intervention known to impact absorption \\[e.g., bariatric surgery or bowel resection\\], or clinically significant esophageal reflux), or surgery that may affect bioavailability as judged by the investigator.",true,"ALL","18 Years","60 Years",{"count":87,"type":88},36,"ESTIMATED","INTERVENTIONAL",[91],"PHASE1","This study will look at how two commonly used medicines, omeprazole and cyclosporine, influence the way the body absorbs, processes, and eliminates velzatinib in healthy volunteers.",[94,95],"Healthy Participants","Gastrointestinal Neoplasms",[97,53,57,98,99,100,47],"Breast cancer resistance protein","Healthy participants","P-glycoprotein","Proton Pump Inhibitor","NOT_YET_RECRUITING","2026-10-01",{"date":104,"type":105},"2026-10-07","ACTUAL",{"date":107,"type":88},"2026-10-16",{"date":109,"type":88},"2027-01-12",{"name":5,"class":6}]