Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie
Age
18–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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):
* 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.
Clareo Health | A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Emraclidine
