A Multiple Ascending Dose Study of Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers

Study Overview
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Brief Summary
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This multiple ascending dose study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.

Detailed Description
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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

Official Title
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A Phase 1, Randomized, Double Blind, Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of NP10679 in Healthy Adults

Conditions
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Stroke, Ischemic, Pain, Postoperative, Substance Abuse, Subarachnoid Hemorrhage

Intervention / Treatment
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* Drug: Placebo
* Drug: NP10679


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo intravenous infusion over 30 minutes, five days of once daily dosing | Drug: Placebo<br>* Placebo via 30 minute infusion once daily for 5 days<br>|
| Experimental: NP10679 25 mg<br>NP10679 25 mg intravenous infusion over 30 minutes, five days of once daily dosing | Drug: NP10679<br>* NP10679 25 mg via 30 minute infusion once daily for 5 days<br>|
| Experimental: NP10679 50 mg<br>NP10679 50 mg intravenous infusion over 30 minutes, five days of once daily dosing | Drug: NP10679<br>* NP10679 25 mg via 30 minute infusion once daily for 5 days<br>|
| Experimental: NP10679 100 mg<br>NP10679 100 mg intravenous infusion over 30 minutes, five days of once daily dosing | Drug: NP10679<br>* NP10679 25 mg via 30 minute infusion once daily for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events as a measure of safety and tolerability | Observed side effects and alteration in laboratory values | 10 days | 
| Plasma concentration of parent drug | Pharmacokinetic parameters during dosing period through 4 days post dosing | 9 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NMDA, GluN2B