[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659783":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":11,"studyPopulation":11,"armGroups":57,"interventions":70,"overallOfficials":78,"centralContacts":82,"locations":11,"responsibleParty":91,"collaborators":11,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":11,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":11,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":118,"whyStopped":11,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":11},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":11},[9,13,15,17,19],{"measure":10,"description":11,"timeFrame":12},"Maximum observed plasma concentration (Cmax)",null,"Up to 936 hours",{"measure":14,"description":11,"timeFrame":12},"Area under the concentration-time curve from time zero 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)",{"measure":20,"description":11,"timeFrame":21},"Renal clearance (CLr)","Up to Day 3",[23,25,28,30,32,34,36,38,40,42,45,48],{"measure":24,"description":11,"timeFrame":12},"Time to maximum observed plasma concentration (Tmax)",{"measure":26,"description":11,"timeFrame":27},"Area under the concentration-time curve from time zero to 48 hours post-dose administration (AUC[0-48])","Up to 48 hours",{"measure":29,"description":11,"timeFrame":12},"Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-last])",{"measure":31,"description":11,"timeFrame":12},"Terminal elimination rate constant",{"measure":33,"description":11,"timeFrame":12},"Apparent terminal phase half-life (t1\u002F2)",{"measure":35,"description":11,"timeFrame":12},"Apparent clearance (CL\u002FF)",{"measure":37,"description":11,"timeFrame":12},"Apparent volume of distribution (Vz\u002FF)",{"measure":39,"description":11,"timeFrame":21},"Total amount of drug excreted into urine",{"measure":41,"description":11,"timeFrame":21},"Percentage of the total dose of drug excreted into urine",{"measure":43,"description":44,"timeFrame":12},"Regression coefficient between pharmacokinetic parameters and measures of renal function","The relationship between PK parameters and measures of renal 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 renal function parameter is associated with an increase in the PK parameter, whereas a negative regression coefficient indicates that an increase in the renal 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 renal-function measure and the PK parameter. Unit of measure: unitless (will be reported as a regression coefficient).",{"measure":46,"description":11,"timeFrame":47},"Number of participants with adverse event (AEs) and serious adverse event (SAEs) by severity","Up to Day 40",{"measure":49,"description":11,"timeFrame":47},"Number of participants with clinically important changes in vital signs, electrocardiograms (ECG), physical examination and clinical laboratory parameters",{"allocation":51,"interventionModel":52,"interventionModelDescription":11,"primaryPurpose":53,"observationalModel":11,"timePerspective":11,"maskingInfo":54},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":55,"maskingDescription":56,"whoMasked":11},"NONE","This is an open label study",[58,63,66],{"label":59,"type":60,"description":11,"interventionNames":61},"Participants with Moderate Renal Impairment receiving velzatinib","EXPERIMENTAL",[62],"Drug: Velzatinib",{"label":64,"type":60,"description":11,"interventionNames":65},"Participants with Severe Renal Impairment receiving velzatinib",[62],{"label":67,"type":68,"description":11,"interventionNames":69},"Participants with Normal Renal Function receiving velzatinib","ACTIVE_COMPARATOR",[62],[71],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"DRUG","Velzatinib","Velzatinib will be administered.",[59,67,64],[77],"GSK6042981\u002FIDRX-42",[79],{"name":80,"affiliation":5,"role":81},"GSK Clinical Trials","STUDY_DIRECTOR",[83,88],{"name":84,"role":85,"phone":86,"phoneExt":11,"email":87},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":89,"role":85,"phone":90,"phoneExt":11,"email":87},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",{"type":92,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659783","phase-1-a-study-to-investigate-the-effects-of-moderate-or-severe-renal-impairment-ri-on-velzatinib-100659783",false,"NCT07867171","A Study to Investigate the Effects of Moderate or Severe Renal Impairment (RI) on Velzatinib","A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of Velzatinib in Participants With Moderate or Severe Renal Impairment Compared to Healthy Participants","Inclusion Criteria:\n\n* Participants are 18 to 80 years of age, inclusive, at the time of signing the Informed consent form (ICF).\n* Participants has stable renal function that can be classified into 1 of 3 groups based on estimated GFR at screening.\n* Participants with moderate\u002Fsevere RI may be taking medications, which in the opinion of the investigator, are believed to be therapeutic but do not affect study drug Absorption, distribution, metabolism, excretion (ADME).\n* The participant has no clinically significant and unstable cardiovascular (CV) or endocrine findings, except as expected by their pre-existing renal condition in the investigator's opinion (participants with renal impairment).\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 (participants with normal renal function).\n\nExclusion Criteria:\n\n* Participants 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 160 millimeters of mercury (mmHg) for systolic BP and 50 to 95 mmHg for diastolic BP (BP to be measured in triplicate), or a semi-supine pulse rate outside the range of 45 to 100 beats per minute (bpm).\n* Participants has orthostatic hypotension such that there is a decrease in systolic BP of greater than equal to (\\>=)20 mmHg or in diastolic BP of \\>=10 mmHg, or pulse rate increase \\>=30 bpm.\n* Has current or chronic history of liver disease (including acute or chronic hepatitis B or hepatitis C) or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) (participants with renal impairment).\n* Has nephrotic syndrome.\n* Has a clinically significant elevation in serum potassium, that in the opinion of the investigator and medical monitor will interfere with the study or introduce additional safety risk to the participant.\n* Has a serum sodium level \\\u003C=125 milliequivalents per Liters (mEq\u002FL) (participants with renal impairment).\n* Has a functioning, likely or planned renal transplant (participants with renal impairment).\n* On dialysis or considered likely to require dialysis during the study (participants with renal impairment).\n* 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":105,"type":106},30,"ESTIMATED","INTERVENTIONAL",[109],"PHASE1","This study evaluates the effect of moderate and severe renal impairment on the pharmacokinetics (PK) of velzatinib compared with normal renal function.",[112,113],"Healthy Participants","Gastrointestinal Neoplasms",[115,116,117,73],"Healthy participants","Renal Impairment","Pharmacokinetics","NOT_YET_RECRUITING","2026-10-01",{"date":121,"type":122},"2026-10-09","ACTUAL",{"date":124,"type":106},"2026-10-23",{"date":126,"type":106},"2027-09-09",{"name":5,"class":6}]