A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Emraclidine

NCT ID: NCT05935033

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2025-02-21

Brief Summary

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.

Conditions

Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Severe Hepatic Impairment

Participants will receive a single oral dose of 10 milligrams (mg) emraclidine.

Group Type: EXPERIMENTAL

Emraclidine

Intervention Type: DRUG

Tablet

Moderate Hepatic Impairment

Participants will receive a single oral dose of 10 mg emraclidine.

Group Type: EXPERIMENTAL

Emraclidine

Intervention Type: DRUG

Tablet

Mild Hepatic Impairment

Participants will receive a single oral dose of 10 mg emraclidine.

Group Type: EXPERIMENTAL

Emraclidine

Intervention Type: DRUG

Tablet

Normal Hepatic Function

Participants will receive a single oral dose of 10 mg emraclidine.

Group Type: EXPERIMENTAL

Emraclidine

Intervention Type: DRUG

Tablet

Interventions

Emraclidine

Tablet

Intervention Type: DRUG

Other Intervention Names

CVL-231

Eligibility Criteria

Inclusion Criteria

1. All Participants

• 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]).

• Participants who are healthy, having no clinically relevant abnormalities. Have normal hepatic function.
• 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.

Exclusion Criteria

1. For All Participants

• 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.
• Receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination or booster within 7 days of planned dosing.
• 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).
• Positive drug screen or a positive test for alcohol at Screening or Baseline (Check-in/Day -1) Visits.
• Use of prohibited medications prior to randomization or likely to require prohibited concomitant therapy during the trial.
• 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.
• Known allergy or hypersensitivity to the investigational medicinal product (IMP), closely related compounds, or any of their specified ingredients.
• Has received IMP in a clinical trial of emraclidine within 12 months of signing the ICF.
• Participants with a 12-lead ECG demonstrating any of the following at the Screening Visit and at Check-in (Day -1):

• QT interval corrected for heart rate using Fridericia's formula (QTcF) interval >470 milliseconds (ms)
• QRS interval >120 ms (unless right bundle branch block)
• PR interval >200 ms
• 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)
• Type 2 second-degree or third-degree atrioventricular block
• Heart rate <45 beats per minute (bpm) or >100 bpm
• Abnormal ECG changes (such as clinically significant ST depression or elevation or T wave inversion).
• Abnormal heart rhythm (such as atrial fibrillation and atrial flutter)
• Blood pressure measurements demonstrating any of the following at the Screening Visit and/or at Check-in (Day -1):

• Supine systolic blood pressure ≥140 millimeters of mercury (mmHg) and/or diastolic blood pressure ≥90 mmHg
• Standing systolic and/or diastolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg
• 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.

• 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
• Acute hepatitis
• Grade ≥2 hepatic encephalopathy
• Participants who have received an organ transplant or are currently waiting for an organ transplant and are listed on the national transplant list.
• Primary biliary cholangitis or primary sclerosing cholangitis
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Miami, Florida

Miami, Florida, United States

Orlando, Florida

Orlando, Florida, United States

San Antonio, Texas

San Antonio, Texas, United States

Countries

United States

Other Identifiers

CVL-231-SP-1008

Identifier Type: -

Identifier Source: org_study_id