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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 day 1 up to follow-up (day 15)
Awards & highlights

Study Summary

This trial looks at how liver health affects the body's response to a medicine.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~day 1 up to follow-up (day 15)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to follow-up (day 15) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine
Area Under the Plasma Concentration-time Curve from Time Zero to t (AUC0-t) of Emraclidine
Area Under the Unbound Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf,u) of Emraclidine
+3 more
Secondary outcome measures
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
+3 more

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
2023
Completed Phase 1
~80

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
35 Previous Clinical Trials
5,675 Total Patients Enrolled

Media Library

Emraclidine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05935033 — Phase 1
Liver Disease Research Study Groups: Severe Hepatic Impairment, Moderate Hepatic Impairment, Mild Hepatic Impairment, Normal Hepatic Function
Liver Disease Clinical Trial 2023: Emraclidine Highlights & Side Effects. Trial Name: NCT05935033 — Phase 1
Emraclidine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05935033 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criteria for this study encompass individuals aged 40 and above?

"According to the set parameters of this experiment, those aged 18-75 are eligible for participation."

Answered by AI

To whom is this trial open for participation?

"For inclusion in this medical investigation, applicants must present with liver disease and be between 18 to 75 years of age. This research is aiming for 40 participants in total."

Answered by AI

Are there still opportunities for individuals to participate in this experiment?

"This clinical trial is currently recruiting participants, as evidenced by the data hosted on clinicaltrials.gov. The initial posting date was June 30th 2023 and it has been recently updated on July 13th of the same year."

Answered by AI

How harmful is Moderate Hepatic Impairment for those affected?

"Due to the limited data surrounding Moderate Hepatic Impairment, our team assessed it a 1 on a scale of safety. This is especially true since this medical trial is still in its Phase 1 stages."

Answered by AI

To what extent is the sample size of this research project?

"Correct. Clinicaltrials.gov report that, since its posting on June 30th 2023 and most recent update of July 13th 2023, this clinical trial is actively searching for 40 participants to take part at one site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Emraclidine
2023. "A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Emraclidine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05935033.
~16 spots leftby Dec 2024
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