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NCT05940402

A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal Renal Function

A Phase 1 Open-label Trial to Evaluate the Pharmacokinetics and Safety Following a Single Dose of Emraclidine in Adult Participants With Mild, Moderate, and Severe Renal Impairment Compared With Adult Participants With Normal Renal Function
Cerevel Therapeutics, LLC·Phase 1·ClinicalTrials.gov·drugRecruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Renal Impairment
Drug/Device/Intervention
Emraclidine
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Cerevel Therapeutics, LLC
Location
Tustin,Miami,Miami,Orlando,Knoxville, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Jul 24, 2023
End date
Jun 01, 2025
Enrollment
60 participants
Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Emraclidine,Maximum Observed Unbound Plasma Concentration (Cmax,u) 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 t (AUC0-t,u) of Emraclidine,Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine,Area Under the Unbound Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf,u) of Emraclidine

Summary

The primary purpose of this study is to assess the effect of renal impairment on the
 pharmacokinetics (PK) of emraclidine following administration of a single oral dose in
 participants with mild, moderate, and severe renal impairment relative to matched
 participants with normal renal function.

ICD-10 classifications
Renal failureDisorders resulting from impaired renal tubular functionDisorder resulting from impaired renal tubular function, unspecifiedOther disorders resulting from impaired renal tubular functionAcute renal failure
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05940402
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05940402 through Pure Global AI's free database. This Phase 1 trial is sponsored by Cerevel Therapeutics, LLC and is currently Recruiting. The study focuses on Renal Impairment. Target enrollment is 60 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.