Pomaglumetad Effects on Glutamate Biomarkers

Healthy Controls Clinical Trial

Official title: Biomarker Assessment of Pomaglumetad on Glutamate Targets: Proof of Clinical Mechanism of Action (POCM)

Status Completed

Clinical Trial Summary

The study will evaluate the effects of the mGluR2/3 partial agonist LY2140023 (Pomaglumetad Methionil, "POMA") at selected doses on ketamine-stimulated glutamate release in prefrontal cortex as measured by pharmacoBOLD fMRI (also termed resting BOLD fMRI).

Clinical Trial Description

This study evaluates the effects of POMA at selected doses on ketamine-stimulated glutamate increase in the prefrontal cortex hypothesized to simulate the synaptic dysregulation that occurs endogenously in the pathogenesis of schizophrenia. The purpose of this is: 1) to determine whether the low dose (40 mg BID) utilized in recent (failed) clinical trials is sufficient to engage the primary target and 2) whether a higher (160 mg BID) dose, representing the maximum tolerated dose of POMA, engages the target to a greater degree. This study will further validate pharmacoBOLD as biomarker of mGluR2/3 target engagement, permitting its future use in other glutamatergic drug development. ;

Related Conditions & MeSH terms

• Healthy Controls

• NCT number: NCT02919774
• Study type: Interventional
• Source: New York State Psychiatric Institute
• Status: Completed
• Phase: Phase 1
• Start date: October 2016
• Completion date: May 25, 2018