[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659130":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":11,"studyPopulation":11,"armGroups":50,"interventions":66,"overallOfficials":74,"centralContacts":78,"locations":11,"responsibleParty":87,"collaborators":11,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":11,"eligibilityCriteria":95,"healthyVolunteers":96,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":11,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":114,"whyStopped":11,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":11},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":11},[9,13,15,17],{"measure":10,"description":11,"timeFrame":12},"Maximum plasma concentration (Cmax)",null,"Up to 936 hours",{"measure":14,"description":11,"timeFrame":12},"Area under the plasma concentration-time curve extrapolated to infinity AUC(0-inf)",{"measure":16,"description":11,"timeFrame":12},"Maximum plasma unbound concentration (Cmax,u)",{"measure":18,"description":11,"timeFrame":12},"Area under the unbound plasma concentration-time curve extrapolated to infinity (AUC[0-inf],u)",[20,22,25,27,29,31,33,35,38,41],{"measure":21,"description":11,"timeFrame":12},"Time to maximum observed plasma drug concentration (Tmax)",{"measure":23,"description":11,"timeFrame":24},"Area under the plasma drug concentration-time curve from time 0 to 48 hours post-dose administration (AUC[0-48])","Up to 48 hours",{"measure":26,"description":11,"timeFrame":12},"Area under the plasma drug concentration-time curve from time 0 to time of the last quantifiable concentration (AUC[0-last])",{"measure":28,"description":11,"timeFrame":12},"Terminal elimination rate constant",{"measure":30,"description":11,"timeFrame":12},"Apparent terminal phase half-life (t1\u002F2)",{"measure":32,"description":11,"timeFrame":12},"Apparent clearance (CL\u002FF)",{"measure":34,"description":11,"timeFrame":12},"Apparent volume of distribution (Vz\u002FF)",{"measure":36,"description":37,"timeFrame":12},"Regression coefficient Between Pharmacokinetic Parameters and Measures of Hepatic Function","The relationship between PK parameters and measures of hepatic function will be evaluated using regression analyses. Regression coefficients will be summarized to describe the direction and magnitude of the relationship. A positive regression coefficient indicates that an increase in the hepatic function parameter is associated with an increase in the PK parameter, whereas a negative regression coefficient indicates that an increase in the hepatic function parameter is associated with a decrease in the PK parameter. A regression coefficient close to zero suggests little or no linear relationship between the hepatic-function measure and the PK parameter. Unit of measure: unitless (will be reported as a regression coefficient).",{"measure":39,"description":11,"timeFrame":40},"Number of participants with adverse events (AEs) and serious adverse events (SAEs) by severity","Up to 40 days",{"measure":42,"description":11,"timeFrame":40},"Number of participants with clinically significant changes in clinical laboratory parameters, physical examinations, Electrocardiogram (ECG) and vital signs",{"allocation":44,"interventionModel":45,"interventionModelDescription":11,"primaryPurpose":46,"observationalModel":11,"timePerspective":11,"maskingInfo":47},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":48,"maskingDescription":49,"whoMasked":11},"NONE","This is an open label study.",[51,56,59,62],{"label":52,"type":53,"description":11,"interventionNames":54},"Participants with mild hepatic impairment receiving Velzatinib","EXPERIMENTAL",[55],"Drug: Velzatinib",{"label":57,"type":53,"description":11,"interventionNames":58},"Participants with moderate hepatic impairment receiving Velzatinib",[55],{"label":60,"type":53,"description":11,"interventionNames":61},"Participants with severe hepatic impairment receiving Velzatinib",[55],{"label":63,"type":64,"description":11,"interventionNames":65},"Participants with normal hepatic function receiving Velzatinib","ACTIVE_COMPARATOR",[55],[67],{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"DRUG","Velzatinib","Velzatinib will be administered",[52,57,63,60],[73],"GSK6042981\u002FIDRX-42",[75],{"name":76,"affiliation":5,"role":77},"GSK Clinical Trials","STUDY_DIRECTOR",[79,84],{"name":80,"role":81,"phone":82,"phoneExt":11,"email":83},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":85,"role":81,"phone":86,"phoneExt":11,"email":83},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",{"type":88,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659130","phase-1-a-study-to-investigate-the-effects-of-impaired-hepatic-function-on-velzatinib-100659130",false,"NCT07859735","A Study to Investigate the Effects of Impaired Hepatic Function on Velzatinib","A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of Velzatinib in Participants With Hepatic Impairment Compared to Healthy Participants","Inclusion Criteria:\n\n* Participant is 18 to 80 years of age, inclusive, at the time of signing the Informed consent form (ICF).\n* Participant has stable hepatic function that can be classified into 1 of 4 groups according to the Child-Pugh and National Cancer Institute Organ Dysfunction Working Group (NCI-ODWG) classification.\n* Participant has stable hepatic function (i.e., no clinically significant change in status according to the investigator's clinical judgment within the preceding 14 days \\[e.g., no worsening of clinical signs of HI, or no worsening of total bilirubin or prothrombin by more than 50 percent\\]) and those needing treatment are on stable doses of medication.\n* Participants with HI may be taking medications, which in the opinion of the investigator, are believed to be therapeutic but do not affect study intervention absorption, distribution, metabolism, excretion (ADME).\n* Has no clinically significant and unstable cardiovascular or endocrine findings, except as expected by their pre-existing hepatic condition in the investigator's opinion.\n* Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring. Participants with chronic disorders such as hypertension and diabetes mellitus can be enrolled, provided those disorders are stable and adequately controlled, but otherwise participants should be considered healthy for their age.\n\nExclusion Criteria:\n\n* Participant 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* Semi-supine blood pressure (BP) outside the ranges of 100 to 140 millimeters of mercury (mmHg) for systolic BP and 50 to 90 mmHg for diastolic BP (BP to be measured in triplicate), or a semi-supine pulse rate outside the range of 45 to 90 beats per minute (bpm).\n* Participant has symptoms arising from orthostatic hypotension such that there is a decrease in systolic BP of greater than or equal to (\\>=) 20 mmHg or in diastolic BP of \\>=10 mmHg, or pulse rate increase \\>=30 bpm.\n* Participant has history of extrahepatic disorders possibly related to etiology of cirrhosis (e.g., nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, uncontrolled hypertension) (for participants with hepatic impairment).\n* Participant has a history of liver or other solid organ transplant including transjugular intrahepatic portosystemic shunt (TIPS) placement (for participants with hepatic impairment).\n* Participant has evidence of acute viral hepatitis within 30 days before dosing with study drug.( for participants with hepatic impairment)\n* Hepatitis B surface antigen (HBsAg) positive participants are allowed to be enrolled if Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) is below 1000 copies per milliliter in the plasma, at Screening. Participants with HI who are positive for hepatitis C virus antibodies (HCVAb) can be enrolled but must not have detectable hepatitis C virus antibodies (HCV) Ribonucleic acid (RNA) on reflex testing, at Screening (for participants with hepatic impairment).\n* The participant has a positive test result for HBsAg or Hepatitis B core antibody (HBcAb) at Screening or within 3 months prior to administration of the study intervention dose (for participants with normal hepatic function).\n* The participant has a positive hepatitis C antibody test result at Screening or within 3 months prior to the administration of the study intervention dose (for participants with normal hepatic function).\n* Participant has regular alcohol consumption within 6 months prior to the study, defined as an average weekly intake of \\>14 units for males and females. One unit is equivalent to 8 grams (g) of alcohol: a half-pint (approximately 240 milliliters \\[mL\\]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.\n* Participant has clinically significant cardiac disease, including second- or third-degree atrioventricular block, clinically significant tachyarrhythmias, or atrial fibrillation\u002Fflutter.",true,"ALL","18 Years","80 Years",{"count":101,"type":102},40,"ESTIMATED","INTERVENTIONAL",[105],"PHASE1","This study evaluates the pharmacokinetics (PK), safety, and tolerability of velzatinib in participants with mild, moderate, and severe hepatic impairment (HI) and participants with normal hepatic function.",[108,109],"Healthy Participants","Gastrointestinal Neoplasms",[111,112,113,69],"Healthy participants","Hepatic Impairment","Pharmacokinetics","NOT_YET_RECRUITING","2026-10-01",{"date":117,"type":118},"2026-10-06","ACTUAL",{"date":120,"type":102},"2026-11-10",{"date":122,"type":102},"2028-04-25",{"name":5,"class":6}]