Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT05330858
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2022-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relative Bioavailability of ESK-001 Tablet Versus Liquid in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064750', 'term': 'Rabeprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-09-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-06', 'studyFirstSubmitDate': '2022-03-30', 'studyFirstSubmitQcDate': '2022-04-14', 'lastUpdatePostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the PK parameters of ESK-001 via time of maximum plasma concentration (Tmax)', 'timeFrame': '18 Days', 'description': 'Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms'}, {'measure': 'Assess the PK parameters of ESK-001 via maximum plasma concentration (Cmax)', 'timeFrame': '18 Days', 'description': 'Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms'}, {'measure': 'Assess the PK parameters of ESK-001 via area under the concentration time curve (AUC)', 'timeFrame': '18 Days', 'description': 'Relative bioavailability and food effect assessment via collection and comparison of PK plasma samples between dosing arms'}], 'secondaryOutcomes': [{'measure': 'Assess the Incidence of Treatment Emergent Adverse Events of ESK-001', 'timeFrame': '25 Days', 'description': 'Collection and review of incidence of adverse events and serious adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'This is a single-center, in-house, open-label, crossover study in 15 healthy participants.', 'detailedDescription': 'This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Men and woman age 18-60\n* Able to provide written informed consent\n* Females can not be pregnant or lactating\n\nExclusion Criteria:\n\n* Prior exposure to ESK-001\n* History of malignancy within the last 10 years\n* Positive for HIV, Hepatitis B or C\n* History of tuberculosis\n* Positive test for alcohol or drugs'}, 'identificationModule': {'nctId': 'NCT05330858', 'briefTitle': 'Relative Bioavailability of ESK-001 Tablet Versus Liquid in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alumis Inc'}, 'officialTitle': 'The Relative Bioavailability of an ESK-001 Tablet Versus Liquid Formulation, and the Effect of Food or Gastric Acid Reduction on the Pharmacokinetics of ESK-001 in Healthy Participants', 'orgStudyIdInfo': {'id': 'ESK-001-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESK-001 Liquid', 'description': 'ESK-001 administered as an oral liquid', 'interventionNames': ['Drug: ESK-001']}, {'type': 'EXPERIMENTAL', 'label': 'ESK-001 Tablet Fasted', 'description': 'ESK-001 administered as an oral tablet in the fasted state', 'interventionNames': ['Drug: ESK-001']}, {'type': 'EXPERIMENTAL', 'label': 'ESK-001 Tablet Fed', 'description': 'ESK-001 administered as an oral tablet in the fed state', 'interventionNames': ['Drug: ESK-001']}, {'type': 'EXPERIMENTAL', 'label': 'ESK-001 and Rabeprazole', 'description': 'ESK-001 administered as an oral tablet with rabeprazole', 'interventionNames': ['Drug: ESK-001', 'Drug: Rabeprazole']}], 'interventions': [{'name': 'ESK-001', 'type': 'DRUG', 'description': 'Oral tablet or liquid', 'armGroupLabels': ['ESK-001 Liquid', 'ESK-001 Tablet Fasted', 'ESK-001 Tablet Fed', 'ESK-001 and Rabeprazole']}, {'name': 'Rabeprazole', 'type': 'DRUG', 'description': 'Oral Tablet', 'armGroupLabels': ['ESK-001 and Rabeprazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Alumis Central Site', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alumis Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}