[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586126":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":29,"locations":35,"responsibleParty":63,"collaborators":28,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":28,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":28,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":28,"overallStatus":38,"whyStopped":28,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Atea Pharmaceuticals, Inc.","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 - Severe Renal Impairment","EXPERIMENTAL","Single dose Bemnifosbuvir (BEM)\u002FRuzasvir (RZR) as a fixed-dose combination",[13],"Drug: Bemnifosbuvir (BEM)\u002FRuzasvir (RZR) as a fixed-dose combination",{"label":15,"type":10,"description":11,"interventionNames":16},"Group 2 - Severe Hepatic Impairment",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Group 3 - Matched Healthy Subjects",[13],[21],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Bemnifosbuvir (BEM)\u002FRuzasvir (RZR) as a fixed-dose combination","A single dose of BEM\u002FRZR will be administered",[9,15,18],[27],"AT-527 (BEM) and AT-038 (RZR)",null,[30],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Atea Study Clinical Trials Administrator","CONTACT","888-481-1607","ateaclinicaltrials@ateapharma.com",[36,53],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Atea Study Site","RECRUITING","Orlando","Florida","32809","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-81.37924,28.53834,{"lat":48,"lon":47},[51],{"name":37,"role":32,"phone":33,"phoneExt":28,"email":52},"AteaClinicalTrials@ateapharma.com",{"facility":37,"status":38,"city":54,"state":40,"zip":55,"country":42,"countryCode":43,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Tampa","33603",{"type":45,"coordinates":57},[58,59],-82.45843,27.94752,{"lat":59,"lon":58},[62],{"name":37,"role":32,"phone":33,"phoneExt":28,"email":52},{"type":64,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100586126","phase-1-study-of-bemnifosbuvirruzasvir-as-a-fixed-dose-combination-in-subjects-with-normal-or-severely-impaired-renal-or-hepatic-function-100586126",false,"NCT06911320","Study of Bemnifosbuvir\u002FRuzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function","A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Safety and Pharmacokinetics of Bemnifosbuvir and Ruzasvir Administered as a Fixed-Dose Combination in Adult Participants With Severe Renal or Hepatic Impairment in Comparison to Healthy Participants","Inclusion Criteria:\n\n* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug\n* Females must have a negative pregnancy test at Screening and prior to dosing\n* BMI of 18.5 to 43.0 kg\u002Fm2\n* Willing to comply with the study requirements and to provide written informed consent\n\nRenal Impaired Subjects (Group 1):\n\n* Considered stable in the judgement of an Investigator\n* Presence of severe renal impairment or kidney failure (as defined by eGFR\\\u003C 30 mL\u002F min)\n\nHepatic Impaired Subjects (Group 2):\n\n* Considered stable for at least 1 month prior to Screening, as per the judgement of an Investigator\n* Presence of severe hepatic impairment (Child-Pugh Class C: score of 10 to 15).\n\nSubjects with Normal Hepatic and Renal Function (Group 3):\n\n* Medically healthy, in the opinion of an Investigator\n* Must match by gender, age (± 10 years), and BMI (within 20%) to the pooled mean values of subjects with severe renal and hepatic impairment\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Infected with hepatitis B virus, hepatitis C virus or HIV\n* Abuse of alcohol or drugs\n* Use of other investigational drugs within 28 days of dosing\n* Other clinically significant medical conditions or laboratory abnormalities\n\nRenal and Hepatic Impaired Subjects (Group 1 and 2):\n\n* Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c \\> 10%\n* Undergoing any method of dialysis\n* Subjects requiring treatment for hepatic impairment or other chronic disease must be on a stable treatment plan\n\nRenal Impaired Subjects (Group 1):\n\n* History of renal transplant\n* Concurrent use of medications known to affect the elimination of serum creatinine\n\nHepatic Impaired Subjects (Group 2):\n\n* History of liver transplant\n* Evidence of hepatic carcinoma presence at Screening",true,"ALL","18 Years","80 Years",{"count":77,"type":78},28,"ESTIMATED","INTERVENTIONAL",[81],"PHASE1","To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir\u002FRuzasvir After a Single Dose",[84,85,86],"Healthy Volunteer Study","Hepatic Impairment","Renal Impairment","2026-04-08",{"date":89,"type":90},"2026-04-13","ACTUAL",{"date":92,"type":90},"2025-04-09",{"date":94,"type":78},"2026-05",{"name":5,"class":6},2]