The purpose of this study is to assess the safety and tolerability of multiple oral (PO) ascending doses of NRX-1074 in normal healthy volunteers.
NRX-1074 is a N-methyl-D-aspartate (NMDA) receptor functional partial agonist with efficacy in animal models of affective disorders including major depressive disorder. The purpose of this study is to evaluate the safety and tolerability of multiple oral (PO) ascending doses of NRX-1074 as evidenced by the incidence and severity of adverse events (AEs), changes in serum chemistry, hematology, and urinalysis, changes in physical examination findings, psychotomimetic findings and subject-reported symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
Single oral administration of placebo consumption on Day 1
Single oral administration of 375 mg consumption on Day 1
Single oral administration of 500 mg consumption on Day 1
Chicago Research Center, Inc.
Chicago, Illinois, United States
Number of participants with adverse events as a measure of safety and tolerability
Observed side effects and changes in laboratory values
Time frame: 28 days following study drug dose
Plasma pharmacokinetics Cmax
Cmax after administration
Time frame: For 24 hours after drug dose on Day 1
Plasma pharmacokinetics - Tmax
Tmax after administration
Time frame: For 24 hours after drug dose on Day 7
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Single oral administration of 750 mg consumption on Day 1