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

NCT05935033 | Completed Phase 1 FDA Drug

• 1 other identifier: CVL-231-SP-1008
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (6)

• Maximum Observed Plasma Concentration (Cmax) of Emraclidine

  Pre-dose and at multiple timepoints post-dose up to Day 7

• Maximum Observed Unbound Plasma Concentration (Cmax,u) of Emraclidine

  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

  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

  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

  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

  Pre-dose and at multiple timepoints post-dose up to Day 7

Secondary Outcomes (6)

• Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)

  Day 1 up to Follow-up (Day 15)

• Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values

  Days 1 to 7

• Number of Participants With Clinically Significant Changes in Vital Signs

  Days 1 to 7

• Number of Participants With Clinically Significant Changes in Laboratory Assessments

  Days 1 to 7

• Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results

  Days 1 to 7

Study Arms (4)

Severe Hepatic Impairment

EXPERIMENTAL

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

Drug: Emraclidine

Moderate Hepatic Impairment

EXPERIMENTAL

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

Drug: Emraclidine

Mild Hepatic Impairment

EXPERIMENTAL

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

Drug: Emraclidine

Normal Hepatic Function

EXPERIMENTAL

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

Drug: Emraclidine

Interventions

Emraclidine DRUG

Tablet

Also known as: CVL-231

Mild Hepatic Impairment; Moderate Hepatic Impairment; Normal Hepatic Function; Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (3)

Miami, Florida

Miami, Florida, 33136, United States

Location

Orlando, Florida

Orlando, Florida, 32809, United States

Location

San Antonio, Texas

San Antonio, Texas, 78215, United States

Location

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 7, 2023
• Study Start: June 30, 2023
• Primary Completion: February 21, 2025
• Study Completion: February 21, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)