This multiple ascending dose study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.
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 stroke, 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 5 once daily doses of NP10679 when delivered intravenously in three escalating dose levels in comparison to placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Pharmaron CPC
Baltimore, Maryland, United States
Incidence of adverse events as a measure of safety and tolerability
Observed side effects and alteration in laboratory values
Time frame: 10 days
Plasma concentration of parent drug
Pharmacokinetic parameters during dosing period through 4 days post dosing
Time frame: 9 days
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