Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 9:56 PM
Study NCT ID:
NCT05935033
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2023-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Emraclidine
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': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2023-06-29', 'studyFirstSubmitQcDate': '2023-06-29', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of Emraclidine', 'timeFrame': 'Pre-dose and at multiple timepoints post-dose up to Day 7'}, {'measure': 'Maximum Observed Unbound Plasma Concentration (Cmax,u) of Emraclidine', 'timeFrame': 'Pre-dose and at multiple timepoints post-dose up to Day 7'}, {'measure': 'Area Under the Plasma Concentration-time Curve from Time Zero to t (AUC0-t) of Emraclidine', 'timeFrame': 'Pre-dose and at multiple timepoints post-dose up to Day 7'}, {'measure': 'Area Under the Unbound Plasma Concentration-time Curve from Time Zero to t (AUC0-t,u) of Emraclidine', 'timeFrame': 'Pre-dose and at multiple timepoints post-dose up to Day 7'}, {'measure': 'Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine', 'timeFrame': 'Pre-dose and at multiple timepoints post-dose up to Day 7'}, {'measure': 'Area Under the Unbound Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf,u) of Emraclidine', 'timeFrame': 'Pre-dose and at multiple timepoints post-dose up to Day 7'}], 'secondaryOutcomes': [{'measure': 'Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Day 1 up to Follow-up (Day 15)'}, {'measure': 'Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values', 'timeFrame': 'Days 1 to 7'}, {'measure': 'Number of Participants With Clinically Significant Changes in Vital Signs', 'timeFrame': 'Days 1 to 7'}, {'measure': 'Number of Participants With Clinically Significant Changes in Laboratory Assessments', 'timeFrame': 'Days 1 to 7'}, {'measure': 'Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results', 'timeFrame': 'Days 1 to 7'}, {'measure': 'Changes in Columbia Suicide Severity Rating Scale (C-SSRS) Score', 'timeFrame': 'Days 1 to 7', 'description': "The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Impairment']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to assess the effect of hepatic impairment on the pharmacokinetics (PK) of emraclidine following administration of a single oral dose in participants with mild, moderate, and severe hepatic impairment relative to matched participants with normal hepatic function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. All Participants\n\n \\- Male and female participants, body mass index of ≥18.0 to 42.0 kilograms per meter square (kg/m\\^2), inclusive, and a total body weight ≥50 kilograms (kg) (110 pounds \\[lbs\\]).\n2. Additional Inclusion Criteria for Participants With Normal Hepatic Function\n\n * Participants who are healthy, having no clinically relevant abnormalities. Have normal hepatic function.\n * Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), bilirubin and prothrombin time ≤ upper limit of normal (ULN) and albumin ≥ lower limit of normal (LLN) and ≤ ULN. Participants with a history of Gilbert syndrome are eligible provided direct bilirubin fraction is \\<20% of total bilirubin, and hemoglobin, and reticulocyte counts are all ≤ ULN.\n3. Additional Inclusion Criteria for Participants With Hepatic Impairment - Participants with stable hepatic impairment that meets the criteria for Class A, Class B, or Class C of the modified Child-Pugh Classification. Stable hepatic disease defined as no clinically significant change in disease status in the last 28 days prior to the screening visit.\n\nKey Exclusion Criteria:\n\n1. For All Participants\n\n * Any condition or surgery that could possibly affect drug absorption, including, but not limited to, bowel resections, bariatric weight loss surgery/procedures, gastrectomy, and cholecystectomy.\n * Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination or booster within 7 days of planned dosing.\n * Have recently been diagnosed with symptomatic coronavirus disease 2019 (COVID-19) or test positive for SARS-CoV-2 within 15 days prior to signing the informed consent form (ICF).\n * Positive drug screen or a positive test for alcohol at Screening or Baseline (Check-in/Day -1) Visits.\n * Use of prohibited medications prior to randomization or likely to require prohibited concomitant therapy during the trial.\n * Current use of tobacco or nicotine-containing products (cigarettes, cigars, chewing tobacco, snuff, e-cigarettes, etc). Note: Light smokers (\\<5 cigarettes/day or equivalent) are allowed provided they abstain from the use of tobacco- or nicotine-containing products for at least 2 hours prior to PK assessments.\n * Known allergy or hypersensitivity to the investigational medicinal product (IMP), closely related compounds, or any of their specified ingredients.\n * Has received IMP in a clinical trial of emraclidine within 12 months of signing the ICF.\n * Participants with a 12-lead ECG demonstrating any of the following at the Screening Visit and at Check-in (Day -1):\n\n * QT interval corrected for heart rate using Fridericia's formula (QTcF) interval \\>470 milliseconds (ms)\n * QRS interval \\>120 ms (unless right bundle branch block)\n * PR interval \\>200 ms\n * Left ventricular hypertrophy (LVH) with ST depressions and/or T wave inversions in leads with relatively tall R waves (ie, LVH with associated ST-T wave abnormalities)\n * Type 2 second-degree or third-degree atrioventricular block\n * Heart rate \\<45 beats per minute (bpm) or \\>100 bpm\n * Abnormal ECG changes (such as clinically significant ST depression or elevation or T wave inversion).\n * Abnormal heart rhythm (such as atrial fibrillation and atrial flutter)\n * Blood pressure measurements demonstrating any of the following at the Screening Visit and/or at Check-in (Day -1):\n\n * Supine systolic blood pressure ≥140 millimeters of mercury (mmHg) and/or diastolic blood pressure ≥90 mmHg\n * Standing systolic and/or diastolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg\n * Orthostatic hypotension, defined as a decrease of ≥20 mmHg in systolic blood pressure and/or ≥10 mmHg in diastolic blood pressure after at least 2 minutes of standing compared with the average of the resting supine blood pressure measurements.\n2. Additional Exclusion Criteria for Participants with Hepatic Impairment\n\n * Estimated glomerular filtration rate (eGFR) \\<60 mL/min/1.73m\\^2 based on the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation at Screening or Check-in (Day -1) visits\n * Acute hepatitis\n * Grade ≥2 hepatic encephalopathy\n * Participants who have received an organ transplant or are currently waiting for an organ transplant and are listed on the national transplant list.\n * Primary biliary cholangitis or primary sclerosing cholangitis\n * ALT or AST \\>5 × ULN or alkaline phosphatase \\>2 × ULN. Participants with a history of Gilbert syndrome are eligible provided direct bilirubin fraction is \\<20% of total bilirubin."}, 'identificationModule': {'nctId': 'NCT05935033', 'briefTitle': 'A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Emraclidine', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 1, Open-label Trial to Evaluate the Pharmacokinetics and Safety Following a Single Dose of Emraclidine in Adult Participants With Mild, Moderate, and Severe Hepatic Impairment Compared With Adult Participants With Normal Hepatic Function', 'orgStudyIdInfo': {'id': 'CVL-231-SP-1008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Severe Hepatic Impairment', 'description': 'Participants will receive a single oral dose of 10 milligrams (mg) emraclidine.', 'interventionNames': ['Drug: Emraclidine']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Hepatic Impairment', 'description': 'Participants will receive a single oral dose of 10 mg emraclidine.', 'interventionNames': ['Drug: Emraclidine']}, {'type': 'EXPERIMENTAL', 'label': 'Mild Hepatic Impairment', 'description': 'Participants will receive a single oral dose of 10 mg emraclidine.', 'interventionNames': ['Drug: Emraclidine']}, {'type': 'EXPERIMENTAL', 'label': 'Normal Hepatic Function', 'description': 'Participants will receive a single oral dose of 10 mg emraclidine.', 'interventionNames': ['Drug: Emraclidine']}], 'interventions': [{'name': 'Emraclidine', 'type': 'DRUG', 'otherNames': ['CVL-231'], 'description': 'Tablet', 'armGroupLabels': ['Mild Hepatic Impairment', 'Moderate Hepatic Impairment', 'Normal Hepatic Function', 'Severe Hepatic Impairment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami, Florida', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando, Florida', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio, Texas', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}