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A Study to Evaluate Pharmacokinetic and Safety Trial of Emraclidine in Participants With Renal Impairment Compared With Participants With Normal Renal Function - Trial NCT05940402

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.

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NCT05940402
Phase 1
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05940402
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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

Study Focus

Renal Impairment

Emraclidine

Interventional

drug

Sponsor & Location

Cerevel Therapeutics, LLC

Tustin,Miami,Miami,Orlando,Knoxville, United States of America

Timeline & Enrollment

Phase 1

Jul 24, 2023

Jun 01, 2025

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 failure
Disorders resulting from impaired renal tubular function
Disorder resulting from impaired renal tubular function, unspecified
Other disorders resulting from impaired renal tubular function
Acute renal failure

Data Source

ClinicalTrials.gov

NCT05940402

Non-Device Trial