Emraclidine for Renal Impairment
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Cerevel Therapeutics, LLC
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing a medication called emraclidine to see how it behaves in people with different levels of kidney function. The study includes participants with mild, moderate, and severe kidney problems and compares them to those with normal kidney function. Researchers want to understand if kidney issues change how the body processes this drug.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. However, participants with renal impairment should have stable concomitant medications for managing their medical history. It's best to discuss your specific situation with the trial team.
What data supports the idea that Emraclidine for Renal Impairment is an effective treatment?
The available research does not provide any data on Emraclidine for Renal Impairment. The studies mentioned focus on other drugs like linezolid and vancomycin, which are used for different conditions and have different effects on renal function. Therefore, there is no information here to support the effectiveness of Emraclidine for Renal Impairment.
12345What safety data is available for Emraclidine in renal impairment?
The provided research does not contain any safety data for Emraclidine (also known as CVL-231, PF-06852231, Emraclidine [INN], J241Y80EEO) in patients with renal impairment. The studies listed focus on other drugs such as linezolid, famotidine, and HIV treatments, but none mention Emraclidine or its related names.
13678Eligibility Criteria
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.Inclusion Criteria
Stable concomitant medications for the management of individual participant's medical history; on a case-by-case basis, with input from the sponsor, participants receiving fluctuating concomitant medication/treatment may be considered if the underlying disease is under control
My kidney function, based on a specific test, shows I have some level of kidney disease.
My kidney function is normal, with an eGFR of 90 mL/min or more.
+6 more
Exclusion Criteria
I have received an organ transplant or am waiting for one.
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.
I do not have any major health issues that could affect my safety or the study results.
+7 more
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Orlando, FloridaOrlando, FL
Knoxville, TennesseeKnoxville, TN
Tustin, CaliforniaTustin, CA
Miami, FloridaMiami, FL
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Who Is Running the Clinical Trial?
Cerevel Therapeutics, LLCLead Sponsor
References
High frequency of linezolid-associated thrombocytopenia and anemia among patients with end-stage renal disease. [2022]Data about the efficacy and tolerability of linezolid for the treatment of gram-positive bacterial infections in patients with end-stage renal disease (ESRD) are lacking.
[Frequency of decreased renal function between patients treated with brand and generic products of vancomycin hydrochloride injection]. [2019]The frequency of decreased renal function was compared between patients treated with brand and generic products of vancomycin injection (VCM) in a retrospective manner based on the clinical examination records archived in Okayama University Hospital. A total of 122 patients were found to have been solely treated with vancomycin injection for MRSA infection, and their examination records were analyzed. The renal function of those patients was evaluated based on the serum creatinine concentration (SCr), and patients whose SCr was maximally elevated above the defined upper limit of the normal range (1.20 mg/dl for males and 0.96 mg/dl for females) were considered to show decreased renal function. Although the amount of VCM administered to patients was larger in the case of generic rather than brand products, the percentage of patients whose renal function was decreased during VCM treatment was not significantly different between the VCM products, in which 2 among 62 patients receiving the brand product and 4 among 60 receiving the generic product were reported to show decreased renal function. It was additionally revealed that 3 of those 4 patients with a decreased renal function related to the generic product were not treated as instructed by the package insert, and their trough VCM concentration exceeded the recommended level of 10 microg/ml. With these findings, the brand and generic VCM products are considered to be similar regarding the adverse effect of decreasing renal function.
Safety Profile of Linezolid in Older Adults With Renal Impairment: A Population-Based Retrospective Cohort Study. [2023]The objective of this study was to characterize the safety profile of linezolid in patients with renal impairment compared with patients without renal impairment.
Effect of atorvastatin on kidney function in chronic kidney disease: a randomised double-blind placebo-controlled trial. [2022]The effect of atorvastatin on kidney function was assessed in patients with stages 2-4 chronic kidney disease.
Optimal vancomycin doses for methicillin-resistant Staphylococcus aureus infection in urological renal dysfunction patients. [2018]To investigate the optimal dose of vancomycin (VCM) for methicillin-resistant Staphylococcus aureus infections in the urological patients including renal dysfunction.
Pharmacokinetics of famotidine, a new H2-receptor antagonist, in relation to renal function. [2019]The pharmacokinetics of a new, potent H2-receptor antagonist, famotidine, 20 mg i.v. was studied in 7 subjects with normal renal function and in 24 patients with varying degrees of renal impairment. The volume of distribution at steady state was 1.141/kg in normal subjects and was not altered in renal failure. The half-life of elimination was 2.59 h in normal subjects and was unchanged in mild renal failure (creatinine clearance, CLCR 90-60 ml/min/1.48 m2) but was increased to 4.72 h in moderate renal failure (CLCR 60-30 ml/min/1.48 m2), and to 12.07 h in severe renal failure (CLCR below 30 ml/min/1.48 m2). The cumulative urinary excretion and renal clearance of famotidine were correspondingly reduced in patients with impaired kidney function. In normal subjects and in patients with mild to moderate renal failure, about 70% of famotidine was excreted through the kidney, mainly by tubular secretion. In patients with a CLCR above 60 ml/min/1.48 m2 the normal daily dose of famotidine can be employed, but in those with a CLCR between 60 and 30 ml/min/1.48 m2 the dose should be reduced by half, and in patients with a CLCR below 30 ml/min/1.48 m2 a reduction by three quarters of the normal dose is recommended.
Safety of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide in HIV-1-infected adults with end-stage renal disease on chronic haemodialysis: an open-label, single-arm, multicentre, phase 3b trial. [2022]Current treatment for HIV-infected individuals with renal failure on haemodialysis frequently requires complex regimens with multiple pills. A daily single-tablet regimen of coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide is approved in Europe, the USA, and in other regions for use in HIV-1-infected individuals with mild-to-moderate chronic kidney disease (creatinine clearance 30-69 mL/min). We aimed to assess the safety, efficacy, and pharmacokinetics of this regimen in HIV-infected adults with end-stage renal disease on chronic haemodialysis.
Elvitegravir/cobicistat/emtricitabine/tenofovir DF in HIV-infected patients with mild-to-moderate renal impairment. [2021]In HIV-1-infected treatment-naive patients with mild-to-moderate renal impairment [creatinine clearance (CrCl): 50-89 mL/min], elvitegravir/cobicistat/emtricitabine/tenofovir DF (STB, n = 33) achieved high rates of virologic success (78.8%; 95% confidence interval: 61.1% to 91.0%) and was well tolerated through week 48. Four patients discontinued study drug due to an adverse event and none due to proximal renal tubulopathy. As expected, decreases in CrCl were noted as early as week 2, after which they stabilized. The renal safety profile of STB in patients from this study is consistent with the long-term experience in a large number of patients with CrCl ≥70 mL/min.
Effect of renal impairment on the pharmacokinetics of PD 0200390, a novel ligand for the voltage-gated calcium channel alpha-2-delta subunit. [2021]To investigate the pharmacokinetics and safety of PD 0200390 in healthy subjects and subjects with renal impairment (RI) and to examine the relationship between oral and renal PD 0200390 clearance and estimated creatinine clearance (CLcr).
Cefsulodin kinetics in renal impairment. [2019]Cefsulodin kinetics were determined after a 500-mg dose to normal subjects and patients with varying degrees of renal insufficiency, including those requiring hemodialysis. Elimination kinetics were described by a two-compartment model. Steady-state volume of distribution was 0.26 l/kg regardless of renal function. When glomerular filtration rate (GFR) was more than 80 ml/min, elimination half-life (t1/2) was 1.9 hr, total body clearance (ClT) was 2.01 ml/kg/min, and renal clearance (ClR) was 1.09 ml/kg/ in. When GFR ranged from 79 to 53 ml/min, t1/2 was 2.9 hr, ClT was 1.17 ml/kg/min, and ClR was 0.65 ml/kg/min. In subjects with moderate renal failure in whom GFR was 32 to 22 ml/min, t1/2 was 5.7 hr, Clt was 0.66 ml/kg/min, and ClR was 0.26 ml/kg/min. In anuric patients t1/2 was 13.0 hr. and ClT was 0.19 ml/kg/min or 9.5% of ClT in normal subjects. There was a linear relationship between ClT and GFR such that ClT = 0.19 + 0.017 GFR (r = 0.95). During hemodialysis the average plasma flow was 122 ml/min, dialyzer plasma clearance was 50.9 ml/min, plasma drug concentration was reduced by 60%, and t1/2 fell to 2.1 hr. After dialysis the elimination rate appeared to return to that in nondialysis studies. Therefore, renal failure reduces the ClT of cefsulodin. In hemodialysis patients the maintenance dose of cefsulodin should be reduced to 10% of normal and 60% of the dose should be given after hemodialysis.
A clinical trial of cephaloridine. [2018]Cephaloridine, a cephalosporin derivative, was administered to 30 selected patients, including 19 with moderate to severe impairment of renal function. This antibiotic eradicated infections due to Staphylococcus pyogenes, and urinary tract infections due to a single member of the species Escherichia coli or Aerobacter aerogenes, which were sensitive to the drug on bacteriological testing. The drug failed in mixed urinary tract infections.No adverse effects were observed except for the development of superinfection in patients with urinary tract infections. No allergic reactions were noted in 10 patients who had reported previous reactions to penicillin.From these studies in patients with renal disease, approximations can be made concerning dose requirements in these special cases. Because of the apparent absence of dose-related toxic effects in humans, cephaloridine was particularly useful in the treatment of patients with renal disease and infections due to susceptible bacteria.
Adjustment of cephaloridine (Keflodin): dosage according to its pharmacokinetics. [2018]The determination of the serum and urine concentrations of cephaloridine permitted calculation of the pharmacokinetic constants of this antibiotic: after administration of a 1-gram intravenous dose in five normal subjects; after administration of a 1-gram intramuscular dose in five normal subjects, five patients with renal impairment and five patients on maintenance hemodialysis. In normal subjects, serum half-life averaged 1.56 h (Ke=0.4445) after intravenous administration and 1.63 h (Ke=0.4254) after intramuscular administration of a 1-gram dose of the antibiotic. The urinary excretion of cephaloridine over the 6 h following its intramuscular administration in normal subjects amounted to 56.4% of the administered dose. The renal clearance of cephaloridine was 194 ml/min. A linear correlation (Ke=0.0670+0.0028 CrCl) was established between overall elimination rate-constant values and the creatinine clearances of the patients under investigation. These data were used to calculate the maintenance and loading doses and intervals adjusted to creatinine clearance values. Accurate dosage regimens adjusted to the renal status of each individual patient were derived from the calculated values.
Pharmacokinetics of ceftizoxime in renal failure patients without dialysis. [2013]To investigate the pharmacokinetics of ceftizoxime (Cef) in renal failure patients without any dialysis and supply the basis for a suitable clinical regimen.