Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-25 @ 7:33 PM
Study NCT ID:
NCT05256732
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2022-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of AT-527 in Healthy Subjects Under Fasting Conditions or With a Meal
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-14', 'studyFirstSubmitDate': '2022-02-16', 'studyFirstSubmitQcDate': '2022-02-16', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (PK) of AT-527', 'timeFrame': 'Day 1', 'description': 'Maximum plasma concentration (Cmax)'}, {'measure': 'Pharmacokinetics (PK) of AT-527', 'timeFrame': 'Day 1', 'description': 'Area under the concentration-time curve (AUC)'}, {'measure': 'Pharmacokinetics (PK) of AT-527', 'timeFrame': 'Day 1', 'description': 'Trough plasma concentration (Ctrough)'}, {'measure': 'Proportions of subjects experiencing treatment-emergent adverse events', 'timeFrame': 'Day 1-10'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteer Study']}, 'descriptionModule': {'briefSummary': 'This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 following oral administration under fasting conditions or with a meal in healthy adult subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 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* Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2\n* Willing to comply with the study requirements and to provide written informed consent\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'}, 'identificationModule': {'nctId': 'NCT05256732', 'briefTitle': 'Study of AT-527 in Healthy Subjects Under Fasting Conditions or With a Meal', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atea Pharmaceuticals, Inc.'}, 'officialTitle': 'Phase 1, Multiple Dose, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-527 Following Oral Administration Under Fasting Conditions or With a Meal in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'AT-03A-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AT-527', 'interventionNames': ['Drug: AT-527 fasted', 'Drug: AT-527 fed']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo Comparator fasted', 'Other: Placebo Comparator fed']}, {'type': 'EXPERIMENTAL', 'label': 'AT-527 BID', 'interventionNames': ['Drug: AT-527']}, {'type': 'EXPERIMENTAL', 'label': 'AT-527 single dose fasted/fed', 'interventionNames': ['Drug: AT-527 single dose']}], 'interventions': [{'name': 'AT-527 fasted', 'type': 'DRUG', 'otherNames': ['Bemnifosbuvir'], 'description': 'AT-527 administered twice daily (BID) for 5 days fasted', 'armGroupLabels': ['AT-527']}, {'name': 'Placebo Comparator fasted', 'type': 'OTHER', 'description': 'Matching placebo administered twice daily (BID) for 5 days fasted', 'armGroupLabels': ['Placebo']}, {'name': 'AT-527 fed', 'type': 'DRUG', 'otherNames': ['Bemnifosbuvir'], 'description': 'AT-527 administered twice daily (BID) for 5 days fed', 'armGroupLabels': ['AT-527']}, {'name': 'Placebo Comparator fed', 'type': 'OTHER', 'description': 'Matching placebo administered twice daily (BID) for 5 days fed', 'armGroupLabels': ['Placebo']}, {'name': 'AT-527', 'type': 'DRUG', 'otherNames': ['Bemnifosbuvir'], 'description': 'AT-527 administered twice daily (BID)', 'armGroupLabels': ['AT-527 BID']}, {'name': 'AT-527 single dose', 'type': 'DRUG', 'otherNames': ['Bemnifosbuvir'], 'description': 'AT-527 single dose fasted/fed cross-over', 'armGroupLabels': ['AT-527 single dose fasted/fed']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Québec', 'state': 'Montreal, Quebec', 'country': 'Canada', 'facility': 'Atea Study Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atea Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}