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A Study of ANAVEX3-71 in Adults With Schizophrenia - Trial NCT06245213

Access comprehensive clinical trial information for NCT06245213 through Pure Global AI's free database. This Phase 2 trial is sponsored by Anavex Life Sciences Corp. and is currently Recruiting. The study focuses on Schizophrenia. Target enrollment is 40 participants.

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NCT06245213
Phase 2
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06245213
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A Study of ANAVEX3-71 in Adults With Schizophrenia
A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Electrophysiology of ANAVEX3-71 in Adult Patients With Schizophrenia in a Multiple Ascending Dose Study (Part A), Followed by a Double-Blind, Randomized, Placebo-Controlled Study (Part B)

Study Focus

Schizophrenia

ANAVEX3-71 oral capsules

Interventional

drug

Sponsor & Location

Anavex Life Sciences Corp.

Marlton, United States of America

Timeline & Enrollment

Phase 2

Mar 15, 2024

May 15, 2025

40 participants

Primary Outcome

Single Dose Maximum Observed Plasma Concentration (Cmax),Multiple Dose Maximum Observed Plasma Concentration (Cmax),Cmax (steady state),Tmax (steady state),AUC (steady state),AUC (single state),CL/F (steady state),Vz/F (steady state),T1/2 (steady state),Rac (steady state),Rac, Cmax (steady state),PTR (steady state),Adverse Events,Vital Signs,12-lead ECG (RR interval),12-lead ECG (P wave),12-lead ECG (PR interval),12-lead ECG (PR segment),12-lead ECG (QRS complex),12-lead ECG (ST segment),12-lead ECG (T wave),12-lead ECG (QT interval),Clinical Safety Labs - Renal Panel,Clinical Safety Labs - Hepatic Panel,Clinical Safety Labs - Lipid Panel,Clinical Safety Labs - Hematology Panel,Clinical Safety Labs - Urinalysis Panel,Clinical Safety Labs - Coagulation Panel,Brief Physical Examination,Brief Neurological Examination,AIMS,SAS,BARS,CDSS,C-SSRS,EEG-ERP - Passive, Duration Deviant, Oddball ERP,EEG-ERP - Active, Auditory, Oddball ERP,EEG-ERP - Auditory Steady State Response,EEG-ERP - Resting EEG

Summary

A study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and
 electrophysiology of ANAVEX3-71 in patients with Schizophrenia.

ICD-10 Classifications

Schizophrenia
Simple schizophrenia
Schizophrenia, unspecified
Other schizophrenia
Paranoid schizophrenia

Data Source

ClinicalTrials.gov

NCT06245213

Non-Device Trial