Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:24 AM
Study NCT ID:
NCT07472361
Status:
RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of ENX-104 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-10', 'studyFirstSubmitDate': '2026-02-24', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Concentration of ENX-104', 'timeFrame': 'Up to Day 16'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to Day 22'}, {'measure': 'Plasma Concentration of Metabolites of ENX-1014', 'timeFrame': 'Up to Day 16'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The study is designed to evaluate the relative bioavailability, safety, and tolerability of a single dose of ENX-104 administered orally as a solution fasted, a tablet fasted, or a tablet with a high fat meal in healthy participants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Biologically female participants (defined as assigned female at birth): a) Of non-childbearing potential, (Note: For female participants with Follicle-Stimulating Hormone \\[FSH\\] levels that are not consistent with postmenopausal status, enrollment will be at the Investigator's discretion and will require a negative pregnancy test Screening and Admission \\[Day -1\\]); b) Of childbearing potential and willing to use highly effective methods of contraception, from Screening until 180 days after the last exposure to study drug, and with a negative pregnancy test at Screening and Admission (Day -1); c) Not currently breastfeeding or lactating, and not intending to initiate breastfeeding during the course of study conduct\n* Biologically male participants (defined as assigned male at birth), if fertile, must be willing to use highly effective contraception, from first Screening through to 3 months after the last dose of study drug\n\nExclusion Criteria:\n\n* Is unable or unwilling to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, should not participate in the study"}, 'identificationModule': {'nctId': 'NCT07472361', 'briefTitle': 'A Study of ENX-104 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Engrail Therapeutics INC'}, 'officialTitle': 'A Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of ENX-104 Administered Orally as a Solution Fasted, a Tablet Fasted, or a Tablet With a High Fat Meal in Healthy Participants', 'orgStudyIdInfo': {'id': 'ENX-104-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment 1', 'interventionNames': ['Drug: ENX-104']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment 2', 'interventionNames': ['Drug: ENX-104']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment 3', 'interventionNames': ['Drug: ENX-104']}], 'interventions': [{'name': 'ENX-104', 'type': 'DRUG', 'description': 'Tablets', 'armGroupLabels': ['Treatment 1', 'Treatment 2', 'Treatment 3']}, {'name': 'ENX-104', 'type': 'DRUG', 'description': 'Oral solution', 'armGroupLabels': ['Treatment 1', 'Treatment 2', 'Treatment 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HA1 3UJ', 'city': 'Middlesex', 'state': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Parexel London EPCU', 'geoPoint': {'lat': 51.53174, 'lon': -0.26856}}], 'centralContacts': [{'name': 'Eve M Taylor, PHD', 'role': 'CONTACT', 'email': 'eve.taylor@engrail.com', 'phone': '18583425478'}], 'overallOfficials': [{'name': 'David George Steel, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parexel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Engrail Therapeutics INC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}