Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-03-09 @ 10:42 PM
Study NCT ID:
NCT03219957
Status:
COMPLETED
Last Update Posted:
2020-02-18
First Post:
2017-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of AT-527 in Healthy and HCV-Infected Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-14', 'studyFirstSubmitDate': '2017-07-13', 'studyFirstSubmitQcDate': '2017-07-14', 'lastUpdatePostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'Through Day 6 for subjects receiving a single dose', 'description': 'Number of subjects experiencing treatment-emergent adverse events'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'Through Day 35 for subjects receiving multiple doses.', 'description': 'Number of subjects experiencing treatment-emergent adverse events'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK) of AT-527', 'timeFrame': 'Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses', 'description': 'Maximum plasma concentration (Cmax)'}, {'measure': 'Pharmacokinetics (PK) of AT-527', 'timeFrame': 'Day 1 for subjects receiving a single dose; Days 1 and 7 for subjects receiving multiple doses', 'description': 'Area under the concentration-time curve (AUC)'}, {'measure': 'Antiviral Activity of AT-527', 'timeFrame': 'Through Day 6 for subjects receiving a single dose; Through Day 35 for subjects receiving multiple doses.', 'description': 'Change from baseline in plasma HCV RNA'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HCV', 'Hepatitis C Virus', 'RNA Viruses', 'Flavivirus', 'Liver Diseases', 'Hepatitis, Viral, Human', 'Flaviviridae Infections'], 'conditions': ['Chronic Hepatitis C', 'Hepatitis C', 'Hepatitis C, Chronic']}, 'referencesModule': {'references': [{'pmid': '31570394', 'type': 'RESULT', 'citation': 'Berliba E, Bogus M, Vanhoutte F, Berghmans PJ, Good SS, Moussa A, Pietropaolo K, Murphy RL, Zhou XJ, Sommadossi JP. Safety, pharmacokinetics and antiviral activity of AT-527, a novel purine nucleotide prodrug, in HCV-infected subjects with and without cirrhosis. Antimicrob Agents Chemother. 2019 Sep 9;63(12):e01201-19. doi: 10.1128/AAC.01201-19. Epub 2019 Sep 30.'}]}, 'descriptionModule': {'briefSummary': 'This study has multiple parts. It will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects and subjects infected with hepatitis C virus (HCV). In addition, the study will assess the antiviral activity of AT-527 in subjects infected with HCV.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll subjects (healthy and HCV-infected subjects):\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* Must have a negative pregnancy test at Screening and prior to dosing\n* Minimum body weight of 50 kg\n* Willing to comply with the study requirements and to provide written informed consent\n\nAdditional inclusion criteria for HCV-infected subjects:\n\n* Must have not received prior treatment for HCV infection\n* Documented clinical history compatible with chronic HCV infection\n* Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening.\n\nExclusion Criteria:\n\nAll subjects (healthy and HCV-infected subjects):\n\n* Pregnant or breastfeeding\n* Infected with hepatitis B 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'}, 'identificationModule': {'nctId': 'NCT03219957', 'briefTitle': 'Study of AT-527 in Healthy and HCV-Infected Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atea Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase I Study Assessing Single and Multiple Doses of AT-527 in Healthy and HCV-Infected Subjects', 'orgStudyIdInfo': {'id': 'AT-01B-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AT-527', 'interventionNames': ['Drug: AT-527']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo Comparator']}], 'interventions': [{'name': 'AT-527', 'type': 'DRUG', 'description': 'Ascending doses of AT-527 administered orally.', 'armGroupLabels': ['AT-527']}, {'name': 'Placebo Comparator', 'type': 'OTHER', 'description': 'Matching placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Chisinau', 'country': 'Moldova', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}], 'overallOfficials': [{'name': 'Xiao-Jian Zhou, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Atea Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atea Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}