Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-28 @ 12:05 AM
Study NCT ID:
NCT04309734
Status:
WITHDRAWN
Last Update Posted:
2022-06-08
First Post:
2020-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D019698', 'term': 'Hepatitis C, Chronic'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000713067', 'term': 'AT-511'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Part A is randomized, double-blind. Part B is open label.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Withdrawn prior to study initiation.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-06', 'studyFirstSubmitDate': '2020-03-13', 'studyFirstSubmitQcDate': '2020-03-13', 'lastUpdatePostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'Through Day 6 for subjects in Part A', 'description': 'Number of subjects experiencing treatment-emergent adverse events'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'Through 4 weeks after end of treatment for subjects in Part B', 'description': 'Number of subjects experiencing treatment-emergent adverse events'}, {'measure': 'Antiviral Activity of AT-777 and AT-527', 'timeFrame': 'Through 2 weeks of treatment for subjects in Part B', 'description': 'Number of subjects who achieve plasma HCV RNA \\< lower limit of quantitation (LLOQ) and target not detected (TND)'}], 'secondaryOutcomes': [{'measure': 'AT-777 maximum plasma concentration (Cmax)', 'timeFrame': 'Day 1 for subjects in Part A', 'description': 'PK'}, {'measure': 'AT-777 area under the concentration-time curve (AUC)', 'timeFrame': 'Day 1 for subjects in Part A', 'description': 'PK'}, {'measure': 'Proportion of subjects achieving sustained virologic response (SVR)', 'timeFrame': '12 weeks after end of treatment for subjects in Part B', 'description': 'SVR defined as the HCV RNA \\< lower limit of quantitation (LLOQ) at 12 weeks after end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C', 'Hepatitis C, Chronic', 'Chronic Hepatitis C', 'Hepatitis C Virus Infection', 'HCV Infection']}, 'descriptionModule': {'briefSummary': 'This study has two parts. Part A will assess the safety, tolerability and pharmacokinetics (PK) of AT-777 in healthy subjects. Part B will assess the safety, antiviral activity/efficacy and PK of AT-777 in combination with AT-527 after 8 weeks of treatment in HCV-infected subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll:\n\n* Body mass index (BMI) of 18-35 kg/m2\n* Must agree to use protocol-specified methods of contraception\n* Negative pregnancy test\n* Willing to comply with the study requirements and to provide written informed consent\n\nAdditional for Part A:\n\n-18-55 years of age\n\nAdditional for Part B:\n\n* 18-65 years of age\n* HCV genotype 1, 2 or 3\n* Documented history compatible with chronic hepatitis C\n* HCV RNA ≥ 10,000 IU/mL at Screening\n\nExclusion Criteria:\n\nAll:\n\n* Pregnant or breastfeeding\n* Abuse of alcohol or drugs\n* Use of other investigational drugs within 30 days of dosing\n* Other clinically significant medical conditions\n\nAdditional for Part B:\n\n* Prior exposure to any HCV NS5A inhibitor\n* Cirrhosis\n* Co-infection with hepatitis B virus or HIV'}, 'identificationModule': {'nctId': 'NCT04309734', 'briefTitle': 'Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atea Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase I/IIa Study Assessing AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects', 'orgStudyIdInfo': {'id': 'AT-01C-001'}, 'secondaryIdInfos': [{'id': '2019-004997-24', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A - 60 mg AT-777 single dose', 'interventionNames': ['Drug: AT-777']}, {'type': 'EXPERIMENTAL', 'label': 'Part A - 120 mg AT-777 single dose', 'interventionNames': ['Drug: AT-777']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A - Placebo single dose', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks', 'interventionNames': ['Drug: AT-777', 'Drug: AT-527']}], 'interventions': [{'name': 'AT-777', 'type': 'DRUG', 'description': 'Administered orally as one or two 60 mg capsule(s) of AT-777 (inhibitor of HCV nonstructural protein 5A (NS5A)), depending on the arm.', 'armGroupLabels': ['Part A - 120 mg AT-777 single dose', 'Part A - 60 mg AT-777 single dose', 'Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally, as one or two placebo capsules, depending on the arm.', 'armGroupLabels': ['Part A - Placebo single dose']}, {'name': 'AT-527', 'type': 'DRUG', 'description': 'Administered orally as one 550 mg tablet of AT-527 (nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase), depending on the arm.', 'armGroupLabels': ['Part B - 60 mg AT-777 + 550 mg AT-527 once daily for 8 weeks']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'overallOfficials': [{'name': 'Xiao-Jian Zhou', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Atea Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atea Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}