CVN058 Effect on Mismatch Negativity in Schizophrenics

NCT ID: NCT03669250

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-09
• Study Completion Date: 2020-03-06

Brief 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.

Detailed Description

Male and female subjects with schizophrenia, age 18 to 50 years old, inclusive, will be randomized to 1 of 6 treatment sequences (Table 2.a) to receive 1 of 3 dose regimens in each period: a single oral administration of CVN058 (15 mg or 150 mg) or matching placebo. The sequence will determine the order in which a subject will take each of the 3 regimens. Discontinued subjects may be replaced at the discretion of the sponsor so that approximately 20 completed subjects are available for analysis.

The study includes three 1-day treatment periods, with a minimum of 7-day washout, maximum 10 day washout (2 total washouts, after Periods 1 and 2) between periods, and a 7-10 day follow-up call post dosing of the last period. Subjects may be inpatients or outpatients at the discretion of the Investigator.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CVN058, low dose

CVN058 prepared in concentrations of 10mg/mL, and are compounded by the clinical site. Subjects will receive one dose of CVN058 at 15mg or 75mg substitution of 15mg.

Group Type: ACTIVE_COMPARATOR

CVN058

Intervention Type: DRUG

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

CVN058, high dose

CVN058 prepared in concentrations of 10mg/mL, and are compounded by the clinical site. Subjects will receive one dose of CVN058 at 150mg.

Group Type: ACTIVE_COMPARATOR

CVN058

Intervention Type: DRUG

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

Placebo

Matching placebo.

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: OTHER

inactive placebo

Interventions

CVN058

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

Intervention Type: DRUG

Placebo comparator

inactive placebo

Intervention Type: OTHER

Other Intervention Names

TAK058

Eligibility Criteria

Inclusion Criteria

• Subjects 18 to 50 years of age, inclusive, at the time of informed consent.
• The subject weighs at least 50 kg and has a body mass index (BMI) between 18 and 40 kg/m2 inclusive at Screening.
• Subject meets schizophrenia criteria as defined by the Diagnostic & Statistical Manual of mental Disorders, 5th Edition (DSM-V).
• Subjects are on a stable dose of antipsychotic medication(s) for at least 2 months prior to - Screening as documented by medical history and assessed by site staff.
• Subject has a Positive and Negative Syndrome Scale (PANSS) total score of <95.

Exclusion Criteria

• Subject currently receiving treatment with any excluded medication or dietary supplement.
• Subjects who have a history of gastrointestinal disease that would influence the absorption of study drug or have a history of any surgical intervention known to impact absorption (e.g., bariatric surgery or bowel resection).
• Subjects having clinical laboratory evaluations (including clinical chemistry, hematology and complete urinalysis) outside the reference range for the testing laboratory, unless the results are deemed to be not clinically significant (NCS) by the investigator at Screening.
• Subjects with moderate to severe substance use disorder, unstable mood or anxiety disorder.
• Subject has a current diagnosis of a significant psychiatric illness other than schizophrenia per DSM-V and is in an acute phase/episode.
• Subject has clinically meaningful hearing loss.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cerevance Alpha, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Kapurch

Role: STUDY_CHAIR

Cerevance, Inc.

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

New York State Psychiatric Institute

New York, New York, United States

Nathan Kline Institute

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CVN058-103

Identifier Type: -

Identifier Source: org_study_id