Baltimore, Maryland 21201

  • Safety Issues

Purpose:

This study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.


Study summary:

NP10679 is a pH dependent inhibitor of the GluN2B subtype of the NMDA receptor. Compounds of this drug class are hypothesized to be beneficial in a number of central nervous system disorders, including brain ischemia associated with subarachnoid hemorrhage, severe pain, major depression and substance abuse disorders. This study uses a double blind, adaptive design approach to evaluate the safety, tolerability and pharmacokinetics of a single dose of NP10679 when delivered intravenously in up to six escalating dose levels in comparison to placebo.


Criteria:

Inclusion Criteria: - Male and female subjects aged 18 to 55 years - Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments. - If of child bearing potential (both men and women) must agree to use 2 forms of contraceptive methods for the duration of study. Exclusion Criteria: - Clinical laboratory values greater than or equal to 2 times the upper limit of normal. - Recent history (within 2 yrs) or current tobacco use.


NCT ID:

NCT03565861


Primary Contact:

Study Chair
Robert Zaczek, Ph.D.
Neurop Inc.


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 24, 2021

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