CVN058 Effect on Mismatch Negativity in Schizophrenics

NCT03669250 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-10-04

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Summary

This is a phase 1, double-blind, placebo-controlled, 3 period cross-over study to evaluate CVN058 target engagement by measuring auditory evoked potential mismatch negativity (MMN) downstream to 5-hydroxytryptamine receptor 3 (5-HT3) as a pharmacodynamic (PD) marker.

Conditions

Interventions

DRUG

CVN058

CVN058 will be given at two doses, a low does and a high dose

OTHER

Placebo comparator

inactive placebo

Sponsors & Collaborators

  • Cerevance Alpha, Inc.

    lead INDUSTRY

Principal Investigators

  • Susan Kapurch · Cerevance, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-09
Primary Completion
2020-03-06
Completion
2020-03-06
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03669250 on ClinicalTrials.gov