Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-31 @ 11:18 AM
Study NCT ID:
NCT05724693
Status:
COMPLETED
Last Update Posted:
2024-07-31
First Post:
2023-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2023-01-24', 'studyFirstSubmitQcDate': '2023-02-02', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax)', 'timeFrame': 'Day 1'}, {'measure': 'Pharmacokinetics (PK) of BEM Area under the plasma concentration-time curve (AUC)', 'timeFrame': 'Day 1'}, {'measure': 'Pharmacokinetics (PK) of BEM AUC', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer', 'Hepatic Impairment']}, 'descriptionModule': {'briefSummary': 'To Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Bemnifosbuvir 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 42.0 kg/m2\n* Willing to comply with the study requirements and to provide written informed consent\n\nSubjects with Normal Hepatic Function (Groups 3 and 5):\n\n* Medically healthy, in the opinion of an Investigator\n* Must match by gender, age (± 10 years), and BMI (± 20%) to the pooled mean values of subjects with hepatic impairment\n\nHepatic Impaired Subjects (Groups 1, 2, and 4):\n\n* Considered stable for at least 1 month prior to Screening, as per the judgement of an Investigator\n* When applicable, presence of mild hepatic impairment (Child-Pugh Class A: score of 5 to 6), moderate hepatic impairment (Child-Pugh Class B: score of 7 to 9) or severe hepatic impairment (Child-Pugh Class C: score of 10 to 15). Hepatic impairment should be stable for at least 1 month prior to Screening\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19\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\nHepatic Impaired Subjects (Groups 1, 2, and 4):\n\n* Currently undergoing any method of dialysis\n* History of liver transplant\n* Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c (HbA1c) \\> 10%\n* Evidence of hepatic carcinoma presence at Screening'}, 'identificationModule': {'nctId': 'NCT05724693', 'briefTitle': 'Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atea Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 1, Multicenter, Open-Label, Parallel-Group, Pharmacokinetic Single Dose Study of Bemnifosbuvir (AT-527) in Adult Subjects With Normal and Impaired Hepatic Function', 'orgStudyIdInfo': {'id': 'AT-03A-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 -Mild Hepatic Impairment', 'description': 'Drug: single dose Bemnifosbuvir (BEM)', 'interventionNames': ['Drug: Bemnifosbuvir (BEM)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2-Moderate Hepatic Impairment', 'description': 'Drug: single dose Bemnifosbuvir (BEM)', 'interventionNames': ['Drug: Bemnifosbuvir (BEM)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 - Healthy Subjects matching mild and moderate impairment groups', 'description': 'Drug: single dose Bemnifosbuvir (BEM)', 'interventionNames': ['Drug: Bemnifosbuvir (BEM)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4 - Severe Hepatic Impairment', 'description': 'Drug: single dose Bemnifosbuvir (BEM)', 'interventionNames': ['Drug: Bemnifosbuvir (BEM)']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5 - Normal hepatic function matching severe impairment group', 'description': 'Drug: single dose Bemnifosbuvir (BEM)', 'interventionNames': ['Drug: Bemnifosbuvir (BEM)']}], 'interventions': [{'name': 'Bemnifosbuvir (BEM)', 'type': 'DRUG', 'otherNames': ['AT-527'], 'description': 'Day 1: A single dose of BEM will be administered', 'armGroupLabels': ['Group 1 -Mild Hepatic Impairment', 'Group 2-Moderate Hepatic Impairment', 'Group 3 - Healthy Subjects matching mild and moderate impairment groups', 'Group 4 - Severe Hepatic Impairment', 'Group 5 - Normal hepatic function matching severe impairment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Atea Study Site Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atea Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}