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Emraclidine Pharmacokinetics in Liver Disease
Phase 1
Recruiting
Research Sponsored by Cerevel Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1 to 7
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how a medication called emraclidine is processed in people with liver problems. It includes participants with mild, moderate, and severe liver issues. The goal is to see how liver function affects the drug's movement and breakdown in the body.
Who is the study for?
This trial is for adults with stable liver disease, classified as Class A, B, or C by the Child-Pugh Classification. They must have a BMI of 18-42 kg/m^2 and weigh at least 50 kg. Healthy participants with normal liver function are also eligible. Exclusions include recent drug trials participation, surgeries affecting drug absorption, COVID-19 diagnosis or vaccination within specific timeframes before the trial, substance abuse, certain medication use, tobacco/nicotine use (except light smokers who abstain before PK assessments), known allergies to emraclidine or its ingredients, abnormal ECG results or blood pressure readings.
What is being tested?
The study tests how different levels of liver impairment affect the body's handling of a single oral dose of Emraclidine compared to those with normal liver function. It measures how much and how quickly Emraclidine appears in the bloodstream and is processed by individuals with varying degrees of hepatic impairment.
What are the potential side effects?
While not explicitly listed in this summary provided information about side effects may include typical reactions to oral medications such as gastrointestinal discomforts like nausea or diarrhea; allergic reactions if sensitivity exists; potential impacts on heart rhythm due to underlying conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1 to 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1 to 7
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Severe Hepatic ImpairmentExperimental Treatment1 Intervention
Participants will receive a single oral dose of 10 milligrams (mg) emraclidine.
Group II: Normal Hepatic FunctionExperimental Treatment1 Intervention
Participants will receive a single oral dose of 10 mg emraclidine.
Group III: Moderate Hepatic ImpairmentExperimental Treatment1 Intervention
Participants will receive a single oral dose of 10 mg emraclidine.
Group IV: Mild Hepatic ImpairmentExperimental Treatment1 Intervention
Participants will receive a single oral dose of 10 mg emraclidine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emraclidine
2024
Completed Phase 1
~110
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for liver disease often target specific pathways to improve liver function and manage symptoms. Ursodeoxycholic acid (UDCA) works by reducing the concentration of toxic bile acids, thus protecting liver cells and improving bile flow.
Antiviral therapies, such as entecavir and tenofovir, inhibit viral replication in hepatitis B, reducing liver inflammation and preventing disease progression. These treatments are crucial for liver disease patients as they help manage symptoms, slow disease progression, and improve overall liver function.
Understanding the pharmacokinetics of these drugs, especially in patients with hepatic impairment, ensures appropriate dosing and minimizes adverse effects, thereby optimizing therapeutic outcomes.
Pharmacotherapies that specifically target ammonia for the prevention and treatment of hepatic encephalopathy in adults with cirrhosis.
Pharmacotherapies that specifically target ammonia for the prevention and treatment of hepatic encephalopathy in adults with cirrhosis.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Cerevel Therapeutics, LLCLead Sponsor
36 Previous Clinical Trials
5,667 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition or had surgery that affects how drugs are absorbed in my body.I have liver problems and my kidney function is reduced.I have received a COVID-19 vaccine or booster in the last 7 days.I am not taking any medications that are not allowed in this trial.I use tobacco or nicotine products, but I am not a heavy smoker.My BMI is between 18.0 and 42.0, and I weigh at least 50 kg.My liver function is stable, but impaired.I was recently diagnosed with COVID-19 or tested positive for it within the last 15 days.My liver functions are within normal ranges.
Research Study Groups:
This trial has the following groups:- Group 1: Severe Hepatic Impairment
- Group 2: Moderate Hepatic Impairment
- Group 3: Mild Hepatic Impairment
- Group 4: Normal Hepatic Function
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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