What side effects are associated with this type of intervention?

Common treatments for liver disease, such as ursodeoxycholic acid (UDCA) for primary biliary cirrhosis, can cause gastrointestinal symptoms like diarrhea and nausea. Direct-acting antivirals (DAAs) for hepatitis C are generally well-tolerated but may cause fatigue, headache, and nausea. Azathioprine, used for severe atopic dermatitis, can lead to lymphopenia, progressive anemia, and transient elevation of liver enzymes. These side effects highlight the importance of monitoring liver function and adjusting dosages as necessary in patients with hepatic impairment.

What prior FDA approvals exist?

FDA-approved treatments for liver diseases include ursodeoxycholic acid (UDCA) for primary biliary cholangitis, which has shown efficacy in improving liver function and delaying disease progression. Obeticholic acid is another approved treatment for patients with an inadequate response to UDCA. For chronic hepatitis C, combinations like sofosbuvir and simeprevir have been approved, with specific dosing adjustments for patients with hepatic impairment. These treatments have undergone extensive pharmacokinetic evaluations to ensure safety and efficacy in patients with varying degrees of liver function.

What other types of research exist?

Promising alternatives to Emraclidine for liver disease patients include Entecavir and Tenofovir for chronic hepatitis B, which have shown efficacy and safety in long-term studies. For chronic hepatitis C, combinations like Ombitasvir-Paritaprevir-Ritonavir plus Dasabuvir have demonstrated high sustained virologic response rates. Additionally, newer treatments such as Sofosbuvir-Velpatasvir-Voxilaprevir are effective for direct-acting antiviral-experienced patients. These alternatives have been evaluated for their pharmacokinetics and safety in patients with hepatic impairment.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1 to 7 for reporting.

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

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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.