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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~up to day 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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 Change in Laboratory Assessments
+3 more

Trial 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
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
5,655 Total Patients Enrolled
Erica KoenigStudy DirectorCerevel Therapeutics, LLC

Media Library

Emraclidine (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05940402 — Phase 1
Kidney Failure Research Study Groups: Mild Renal Impairment, Moderate Renal Impairment, Severe Renal Impairment, Normal Renal Function
Kidney Failure Clinical Trial 2023: Emraclidine Highlights & Side Effects. Trial Name: NCT05940402 — Phase 1
Emraclidine (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05940402 — Phase 1
Kidney Failure Patient Testimony for trial: Trial Name: NCT05940402 — Phase 1

Frequently Asked Questions

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

Are participants being accepted for this clinical experimentation?

"Affirmative. Clinicaltrials.gov displays that this investigation has commenced recruitment and is in need of 60 subjects from 4 centres, with the trial's original announcement coming on July 24th 2023 and last edited on August 2nd 2023."

Answered by AI

Has the FDA approved Severe Renal Impairment for use?

"Owing to the fact that this is an early phase clinical trial, Severe Renal Impairment has been rated a 1 on our scale of safety as there is limited evidence backing both efficacy and safety."

Answered by AI

Are there any North American medical centers presently conducting this scientific investigation?

"Per the current information, 4 sites are currently (and actively) running this clinical trial. The locations include Miami, Orlando and Knoxville as well as other nearby areas; thus, it is important for potential participants to select a centre that minimizes their need for travel."

Answered by AI

Do individuals below the age of 80 meet the criteria for participation in this experiment?

"The study seeks to include adults from the age of 18 up until 75. Separately, there are 7 trials for minors and 161 studies open to participants above 65 years old."

Answered by AI

What is the upper limit for participants in this medical study?

"Affirmative. Clinicaltrials.gov attests to the fact that this research trial is currently recruiting patients, and was first listed on July 24th 2023 before being updated lastly on August 2nd of the same year. It requires 60 participants from 4 separate medical facilities."

Answered by AI

What type of participant is best suited for this clinical research?

"This clinical trial is currently recruiting 60 individuals with renal impairment to test a new medication. Acceptable candidates must have an age between 18 and 75, a Body Mass Index (BMI) of at least 18.0-42.0 kilograms per metre squared (kg/m^2), and total body weight of ≥50 kgs (110 lbs). For eligible participants with normal renal function, they should be within 10 years from the median age for those in the renal impairment groups, their bodyweight should not deviate more than 15 kg from that group's median value; healthy based on medical evaluation including history taking, physical exam findings etc"

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Orlando, Florida
Knoxville, Tennessee
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

To support clinical research.
PatientReceived no prior treatments

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Phone Call
Most responsive sites:
  1. Orlando, Florida: < 24 hours
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal Renal Function
2023. "A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal Renal Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05940402.
All > Knoxville
~28 spots leftby Jan 2025
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