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Emraclidine for Renal Impairment
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
Mild, moderate, or severe renal impairment based on eGFR determined using the 2021 CKD-EPI equation. Renal function assessed at Baseline (Check-in/Day -1) should not deviate more than 30% from the Screening value
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])
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 15
Awards & highlights
Study Summary
This trial looks at how different levels of kidney function affect how a medicine is absorbed in the body.
Who is the study for?
This trial is for adults with varying degrees of kidney function, from normal to severe impairment. Participants must have a BMI between 18.0 and 42.0 kg/m^2 and weigh at least 50 kg. Women who can bear children should use birth control during the study and for a week after the last dose. People with recent COVID-19, substance abuse issues, or significant health problems other than kidney disease are excluded.Check my eligibility
What is being tested?
The trial is testing Emraclidine's effects in people with different levels of kidney health by giving them one oral dose and seeing how their bodies process it compared to those with normal kidneys.See study design
What are the potential side effects?
Potential side effects aren't specified here but generally could include reactions where the drug was given, changes in blood tests or vital signs, or any unusual symptoms that might be related to taking Emraclidine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, based on a specific test, shows I have some level of kidney disease.
Select...
My BMI is between 18 and 42, and I weigh at least 50 kg (110 lbs).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 15
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 moreSecondary 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 Change in Laboratory Assessments
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Severe Renal ImpairmentExperimental Treatment1 Intervention
Participants will receive a single oral dose of 10 mg emraclidine on Day 1.
Group II: Normal Renal FunctionExperimental Treatment1 Intervention
Participants will receive a single oral dose of 10 mg emraclidine on Day 1.
Group III: Moderate Renal ImpairmentExperimental Treatment1 Intervention
Participants will receive a single oral dose of 10 mg emraclidine on Day 1.
Group IV: Mild Renal ImpairmentExperimental Treatment1 Intervention
Participants will receive a single oral dose of 10 milligrams (mg) emraclidine on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emraclidine
2024
Completed Phase 1
~90
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
5,659 Total Patients Enrolled
Erica KoenigStudy DirectorCerevel Therapeutics, LLC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function, based on a specific test, shows I have some level of kidney disease.I have received an organ transplant or am waiting for one.My kidney function is normal, with an eGFR of 90 mL/min or more.If you have had thoughts about wanting to die or have made plans to harm yourself, or if your doctor thinks you are at serious risk of suicide, you cannot participate in the trial. If you had these thoughts in the past, but not in the last year, the doctor will need to talk to the study's medical monitor before you can join the trial.My age is close to the average for people with kidney issues in the study.I do not have any major health issues that could affect my safety or the study results.I require dialysis.My weight is within the normal range for people with kidney issues.I do not plan to get a COVID-19 vaccine or booster during the trial or within 7 days after the last dose of the trial medication.My BMI is between 18 and 42, and I weigh at least 50 kg (110 lbs).I have symptoms or test results that cannot be explained by my known health issues.I have COVID-19 symptoms or tested positive for COVID-19 in the last 15 days.I have been diagnosed with nephrotic syndrome.I have received a COVID-19 vaccine or booster in the last 7 days.My kidney function has been stable for the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Mild Renal Impairment
- Group 2: Moderate Renal Impairment
- Group 3: Severe Renal Impairment
- Group 4: Normal Renal 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.
Kidney Failure Patient Testimony for trial: Trial Name: NCT05940402 — Phase 1
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