Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-01-19 @ 3:21 AM
Study NCT ID:
NCT06601192
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2024-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Effects of Zelicapavir (EDP-938) on QTc Interval in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723099', 'term': 'EDP-938'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2024-08-27', 'studyFirstSubmitQcDate': '2024-09-13', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-matched, placebo-corrected change-from-baseline QTc based on the Fridericia correction QTcF (ΔΔQTcF) after TD and SD of Zelicapavir', 'timeFrame': 'Up to 24 hours post dose'}], 'secondaryOutcomes': [{'measure': 'Time-matched, placebo-corrected, change-from-baseline non-QT intervals after TD and SD of Zelicapavir', 'timeFrame': 'Up to 24 hours post dose'}, {'measure': 'Time-matched, placebo-corrected, change-from-baseline HR after TD and SD of Zelicapavir', 'timeFrame': 'Up to 24 hours post dose'}, {'measure': 'Concentration-QTc analysis based on the relationship between plasma concentrations of zelicapavir and ΔΔQTcF after a TD and SD of zelicapavir', 'timeFrame': 'Up to 96 hours post dose'}, {'measure': 'Cmax of zelicapavir', 'timeFrame': 'Up to 96 hours post dose'}, {'measure': 'Tmax of zelicapavir', 'timeFrame': 'Up to 96 hours post dose'}, {'measure': 't1/2 of zelicapavir', 'timeFrame': 'Up to 96 hours post dose'}, {'measure': 'Vd/F of zelicapavir', 'timeFrame': 'Up to 96 hours post dose'}, {'measure': 'CL/F of zelicapavir', 'timeFrame': 'Up to 96 hours post dose'}, {'measure': 'ΔΔQTcF after moxifloxacin dosing', 'timeFrame': 'Up to 24 hours post dose'}, {'measure': 'Safety measured by adverse events', 'timeFrame': 'Up to Day 33'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['RSV Infection', 'QTc Interval']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the effect of a therapeutic and supratherapeutic dose of zelicapavir on the corrected cardiac QT interval relative to a placebo and positive control in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* An informed consent document signed and dated by the subject.\n* Male or female individuals who are 18 to 65 years of age, inclusive\n* Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg\n* Heterosexually active male participants and their female partners of childbearing potential must agree to use 2 effective birth control methods for the duration of the study and for 90 days after the last dose of study intervention.\n* Females of childbearing potential must agree to use 2 effective birth control methods for the duration of the study and for 30 days after the last dose of study intervention.\n\nExclusion Criteria:\n\n* Clinically relevant evidence or history of illness or disease\n* Clinically relevant risk factors for cardiovascular abnormalities\n* Pregnant or nursing females\n* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection\n* Infection with HIV, HBV, HCV, or SARS CoV 2\n* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy)\n* Before the first dose of study intervention, participant has received any vaccine, an investigational agent or biological product within 28 days or 5 times the terminal half-life (t½), whichever is longer\n* A positive urine drug screen at Screening or Day -1\n* Current tobacco smokers or use of tobacco within 3 months prior to Screening\n* History of regular alcohol consumption'}, 'identificationModule': {'nctId': 'NCT06601192', 'briefTitle': 'A Study to Investigate the Effects of Zelicapavir (EDP-938) on QTc Interval in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Enanta Pharmaceuticals, Inc'}, 'officialTitle': 'Phase 1, Randomized, Double-Blind Four-Period Crossover, Thorough QT/QTc Study to Evaluate the Effects of EDP-938 on Cardiac Repolarization in Healthy Adults', 'orgStudyIdInfo': {'id': 'EDP 938-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'zelicapavir Dose 1 (therapeutic dose)', 'description': 'All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25.', 'interventionNames': ['Drug: zelicapavir (therapeutic dose)']}, {'type': 'EXPERIMENTAL', 'label': 'zelicapavir Dose 2 (supratherapeutic dose)', 'description': 'All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25.', 'interventionNames': ['Drug: zelicapavir (supratherapeutic dose)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'moxifloxacin', 'description': 'All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25.', 'interventionNames': ['Drug: moxifloxacin']}], 'interventions': [{'name': 'zelicapavir (therapeutic dose)', 'type': 'DRUG', 'otherNames': ['EDP-938'], 'description': 'Subjects will receive zelicapavir (TD) once per treatment period.', 'armGroupLabels': ['zelicapavir Dose 1 (therapeutic dose)']}, {'name': 'zelicapavir (supratherapeutic dose)', 'type': 'DRUG', 'otherNames': ['EDP-938'], 'description': 'Subjects will receive zelicapavir (SD) once per treatment period.', 'armGroupLabels': ['zelicapavir Dose 2 (supratherapeutic dose)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subjects will receive zelicapavir matching placebo once per treatment period.', 'armGroupLabels': ['placebo']}, {'name': 'moxifloxacin', 'type': 'DRUG', 'description': 'Subjects will receive moxifloxin once per treatment period.', 'armGroupLabels': ['moxifloxacin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'ICON', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '78290', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'ICON Early Phase, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Enanta Pharmaceuticals, Inc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Enanta Pharmaceuticals, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Enanta Pharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}