Hepatic ImpairmentPhase 1NCT05935033
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Emraclidine
A Phase 1 study testing Emraclidine in people with Hepatic Impairment, run by AbbVie at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Emraclidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jun 2023to 21 Feb 2025
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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]).
- Additional Inclusion Criteria for Participants With Normal Hepatic Function
- 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.
- 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.
Who cannot join
- 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.
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- 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.
- Additional Exclusion Criteria for Participants with Hepatic Impairment
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Miami, Florida
Miami, Florida, 33136
Orlando, Florida
Orlando, Florida, 32809
San Antonio, Texas
San Antonio, Texas, 78215
About this study
Official title: 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
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
- Being tested
- Emraclidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmraclidineDrug
Also called CVL-231
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Severe Hepatic Impairment | Experimental | Participants will receive a single oral dose of 10 milligrams (mg) emraclidine. Receives: Drug: Emraclidine |
| Moderate Hepatic Impairment | Experimental | Participants will receive a single oral dose of 10 mg emraclidine. Receives: Drug: Emraclidine |
| Mild Hepatic Impairment | Experimental | Participants will receive a single oral dose of 10 mg emraclidine. Receives: Drug: Emraclidine |
| Normal Hepatic Function | Experimental | Participants will receive a single oral dose of 10 mg emraclidine. Receives: Drug: Emraclidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Measured: Pre-dose and at multiple timepoints post-dose up to Day 7
Maximum Observed Unbound Plasma Concentration (Cmax,u) of Emraclidine
Measured: Pre-dose and at multiple timepoints post-dose up to Day 7
Area Under the Plasma Concentration-time Curve from Time Zero to t (AUC0-t) of Emraclidine
Measured: Pre-dose and at multiple timepoints post-dose up to Day 7
Area Under the Unbound Plasma Concentration-time Curve from Time Zero to t (AUC0-t,u) of Emraclidine
Measured: Pre-dose and at multiple timepoints post-dose up to Day 7
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine
Measured: Pre-dose and at multiple timepoints post-dose up to Day 7
Area Under the Unbound Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf,u) of Emraclidine
Measured: Pre-dose and at multiple timepoints post-dose up to Day 7
Secondary outcomes (6)
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Measured: Day 1 up to Follow-up (Day 15)
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
Measured: Days 1 to 7
Number of Participants With Clinically Significant Changes in Vital Signs
Measured: Days 1 to 7
Number of Participants With Clinically Significant Changes in Laboratory Assessments
Measured: Days 1 to 7
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Measured: Days 1 to 7
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) Score
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.
Measured: Days 1 to 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start30 Jun 2023
- Primary completion21 Feb 2025
- Study completion21 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935033
- Sponsor's protocol ID
- CVL-231-SP-1008
- Status last verified
- Apr 2025
- First submitted
- 29 Jun 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No