Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-03-03 @ 2:42 PM
Study NCT ID:
NCT06952634
Status:
RECRUITING
Last Update Posted:
2025-05-01
First Post:
2025-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2025-04-29', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': '48 hours'}, {'measure': 'Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]', 'timeFrame': '48 hours'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation', 'timeFrame': '48 hours'}, {'measure': 'Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Impairment']}, 'descriptionModule': {'briefSummary': 'This a phase 1, open label, single dose, parallel cohort study to determine the pharmacokinetics (PK) of study drug (ESK-001) in healthy volunteer participants, and participants with mild, moderate, and severe hepatic impairment.', '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', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria for All Participants:\n\n* Body mass index between 18.0 and 40.0 kg/m2\n\nKey Inclusion Criteria for Participants with Hepatic Impairment:\n\n* Diagnosis of chronic (\\> 6 months), stable hepatic impairment with no clinically significant changes within 30 days prior to dosing, as determined by medical history\n\nKey Exclusion Criteria for All Participants:\n\n* Uncontrolled treated/untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg), or uncontrolled treated/untreated hypotension (systolic blood pressure \\< 90 mmHg and/or diastolic blood pressure \\< 50 mmHg), or resting pulse rate \\< 45 or \\> 100 bpm. Measurements may be repeated once in order to determine eligibility\n\nKey Exclusion Criteria for Healthy Volunteer:\n\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee.\n* Positive hepatitis panel and/or positive human immunodeficiency virus test.\n\nKey Exclusion Criteria for Participants with Hepatic Impairment:\n\n* History of any uncontrolled or unstable renal, hematological, gastrointestinal, neurological, endocrine, or psychiatric disorder, as determined by the investigator or designee, within 6 months prior to screening.\n* History or current diagnosis of uncontrolled or significant cardiac disease indicative of a significant risk of safety for participation in the study.\n* Liver function tests outside the appropriate reference ranges that are not consistent with hepatic dysfunction, as determined by the investigator or designee.\n* QTcF \\> 480 ms for males or \\> 490 ms for females at screening or check-in, as confirmed from the mean of the original value and 2 repeats.'}, 'identificationModule': {'nctId': 'NCT06952634', 'briefTitle': 'An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alumis Inc'}, 'officialTitle': 'A Phase 1, Open Label, Single Dose Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of ESK001', 'orgStudyIdInfo': {'id': 'ESK-001-022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Volunteer', 'description': 'Up to 24 healthy volunteer participants will receive a single dose of ESK-001', 'interventionNames': ['Drug: ESK-001']}, {'type': 'EXPERIMENTAL', 'label': 'Mild Hepatic Impairment', 'description': '8 participants with mild hepatic impairment will receive a single dose of ESK-001', 'interventionNames': ['Drug: ESK-001']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Hepatic Impairment', 'description': '8 participants with moderate hepatic impairment will receive a single dose of ESK-001', 'interventionNames': ['Drug: ESK-001']}, {'type': 'EXPERIMENTAL', 'label': 'Severe Hepatic Impairment', 'description': '8 participants with severe hepatic impairment will receive a single dose of ESK-001', 'interventionNames': ['Drug: ESK-001']}], 'interventions': [{'name': 'ESK-001', 'type': 'DRUG', 'description': 'Single oral dose of ESK-001 in participants from all cohorts', 'armGroupLabels': ['Healthy Volunteer', 'Mild Hepatic Impairment', 'Moderate Hepatic Impairment', 'Severe Hepatic Impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92630', 'city': 'Lake Forest', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joel Neutel, Medical Director', 'role': 'CONTACT', 'email': 'NeutelMD@OCResesarchCenter.com', 'phone': '714-550-9990'}, {'name': 'Joel Neutel, Medical Director', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Orange County Research Center', 'geoPoint': {'lat': 33.64697, 'lon': -117.68922}}, {'zip': '33104', 'city': 'Miami Lakes', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nicole Revoredo', 'role': 'CONTACT', 'email': 'nrevoredo!@panaxcr.com', 'phone': '305-698-4500'}, {'name': 'Robert Perry, Medical Director', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Panax Clinical Research', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Derek Bell', 'role': 'CONTACT', 'email': 'dbell@ocrc.net', 'phone': '407-240-7878'}, {'name': 'Thomas Marbury, Medical Director', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '37920', 'city': 'Knoxville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Suzann Cloninger', 'role': 'CONTACT', 'email': 'Suzanncloninger@amrllc.com', 'phone': '(865) 410 8300'}, {'name': 'William Smith, Medical Director', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alliance for Multispecialty Research', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}], 'centralContacts': [{'name': 'Central Contact', 'role': 'CONTACT', 'email': 'nharada@alumis.com', 'phone': '(650) 231-6625'}], 'overallOfficials': [{'name': 'Jorn Drappa, Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alumis Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The Sponsor Alumis Inc. is a clinical-stage pharmaceutical company that has not yet adopted an Individual Participant Data (IPD) sharing plan.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alumis Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}