Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT06911320
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713067', 'term': 'AT-511'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2025-03-28', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK) of BEM/RZR Maximum plasma concentration (Cmax)', 'timeFrame': 'Day 1'}, {'measure': 'Pharmacokinetics (PK) of BEM/RZR Area under the plasma concentration-time curve (AUC)', 'timeFrame': 'Day 1'}, {'measure': 'Pharmacokinetics (PK) of BEM/RZR AUC', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer Study', 'Hepatic Impairment', 'Renal Impairment']}, 'descriptionModule': {'briefSummary': 'To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': '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/m2\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\\< 30 mL/ 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'}, 'identificationModule': {'nctId': 'NCT06911320', 'briefTitle': 'Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atea Pharmaceuticals, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'AT-01B-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 - Severe Renal Impairment', 'description': 'Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination', 'interventionNames': ['Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 - Severe Hepatic Impairment', 'description': 'Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination', 'interventionNames': ['Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 - Matched Healthy Subjects', 'description': 'Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination', 'interventionNames': ['Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination']}], 'interventions': [{'name': 'Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination', 'type': 'DRUG', 'otherNames': ['AT-527 (BEM) and AT-038 (RZR)'], 'description': 'A single dose of BEM/RZR will be administered', 'armGroupLabels': ['Group 1 - Severe Renal Impairment', 'Group 2 - Severe Hepatic Impairment', 'Group 3 - Matched Healthy Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Atea Study Site', 'role': 'CONTACT', 'email': 'AteaClinicalTrials@ateapharma.com', 'phone': '888-481-1607'}], 'facility': 'Atea Study Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Atea Study Site', 'role': 'CONTACT', 'email': 'AteaClinicalTrials@ateapharma.com', 'phone': '888-481-1607'}], 'facility': 'Atea Study Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'centralContacts': [{'name': 'Atea Study Clinical Trials Administrator', 'role': 'CONTACT', 'email': 'ateaclinicaltrials@ateapharma.com', 'phone': '888-481-1607'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atea Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}