A Translational and Neurocomputational Evaluation of a Dopamine Receptor 1 Partial Agonist for Schizophrenia

Summary

This study will test whether CVL-562 (PF-06412562), a dopamine 1 partial agonist novel compound, affects working memory neural circuits in patients with early episode schizophrenia. The overall aim is to establish neuroimaging biomarkers of the Dopamine Receptor 1/Dopamine Receptor 5 Family (D1R/D5R) target engagement to accelerate development of D1R/D5R agonists in humans to treat cognitive impairments that underlie functional disability in schizophrenia, a key unaddressed clinical and public health concern.

Conditions

• Early Course Schizophrenia Spectrum Disorder

Interventions

DRUG

CVL-562 (PF-06412562) 1 mg

Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Each test visit will be separated by at least 48 hours (six half-lives of CVL-562 (PF-06412562)).

DRUG

CVL-562 (PF-06412562) 4 mg

Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Each test visit will be separated by at least 48 hours (six half-lives of CVL-562 (PF-06412562)).

DRUG

CVL-562 (PF-06412562) 15 mg

Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Each test visit will be separated by at least 48 hours (six half-lives of CVL-562 (PF-06412562)).

DRUG

CVL-562 (PF-06412562) 25 mg

Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Each test visit will be separated by at least 48 hours (six half-lives of CVL-562 (PF-06412562)).

OTHER

Placebo

Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Each test visit will be separated by at least 48 hours (six half-lives of CVL-562 (PF-06412562)).

Sponsors & Collaborators

• Columbia University

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• State University of New York Stony Brook

  collaborator UNKNOWN

• Cerevel Therapeutics, LLC

  collaborator INDUSTRY

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Yale University

  lead OTHER

Principal Investigators

• John Krystal, MD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-02

Primary Completion

2024-03-22

Completion

2024-03-22

FDA Drug

Yes

Countries

• United States

Study Locations