[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Atea Pharmaceuticals, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100617109","phase-1-drug-drug-interaction-study-of-bemnifosbuvirruzasvir-bemrzr-and-buprenorphinenaloxone-or-methadone-100617109",false,"NCT07314346","Drug-drug Interaction Study of Bemnifosbuvir\u002FRuzasvir (BEM\u002FRZR) and Buprenorphine\u002FNaloxone or Methadone","A Phase 1, Open-Label, Two-Part, Single-Sequence Study to Evaluate the Effect of Multiple Oral Doses of BEM\u002FRZR FDC on the Pharmacokinetics of Buprenorphine\u002FNaloxone or Methadone in Participants on Stable Maintenance Therapy for Opiate Withdrawal","Inclusion Criteria:\n\n* Must agree to use acceptable contraceptive methods through at least 90 days after the last dose of study drug.\n* Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg\u002F m2.\n* Willing to comply with the study requirements and to provide written informed consent.\n\nExclusion Criteria:\n\n* Infected with hepatitis B virus, hepatitis C virus, HIV.\n* Abuse of alcohol or drugs.\n* Use of other investigational drugs within 28 days prior to Day -5.\n* Concomitant use of prescription medications, or systemic over-the-counter medications (apart from methadone or buprenorphine\u002Fnaloxone as assigned maintenance therapy).\n* Other clinically significant medical conditions or laboratory abnormalities.",true,"ALL","18 Years","65 Years",{"count":21,"type":22},32,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","Drug-drug interaction study between Bemnifosbuvir\u002FRuzasvir (BEM\u002FRZR) and Buprenorphine\u002FNaloxone or Methadone",[28],"Healthy Volunteer Study","RECRUITING","2026-04-08",{"date":32,"type":33},"2026-04-13","ACTUAL",{"date":35,"type":33},"2025-01-07",{"date":37,"type":22},"2026-06",{"name":39,"class":40},"Atea Pharmaceuticals, Inc.","INDUSTRY",3,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":5},"100586126","phase-1-study-of-bemnifosbuvirruzasvir-as-a-fixed-dose-combination-in-subjects-with-normal-or-severely-impaired-renal-or-hepatic-function-100586126","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","80 Years",{"count":51,"type":22},28,[25],"To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir\u002FRuzasvir After a Single Dose",[28,55,56],"Hepatic Impairment","Renal Impairment",{"date":32,"type":33},{"date":59,"type":33},"2025-04-09",{"date":61,"type":22},"2026-05",{"name":39,"class":40},""]