Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers

Study Overview
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Brief Summary
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This 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 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.

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

Conditions
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Safety Issues

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
Interventional Model Description: Adaptive design of placebo and up to six escalating doses of NP10679
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo intravenous 30 minute infusion on day 1 | Drug: Placebo<br>* Intravenous vehicle<br>|
| Experimental: NP10679 5 mg<br>NP10679 5 mg intravenous infusion on day 1 | Drug: NP10679<br>* NP10679<br>|
| Experimental: NP10679 15 mg<br>NP10679 15 mg intravenous infusion on day 1 | Drug: NP10679<br>* NP10679<br>|
| Experimental: NP10679 50 mg<br>NP10679 50 mg intravenous infusion on day 1 | Drug: NP10679<br>* NP10679<br>|
| Experimental: NP10679 100 mg<br>NP10679 100 mg intravenous infusion on day 1 | Drug: NP10679<br>* NP10679<br>|
| Experimental: NP10679 200 mg<br>NP10679 200 mg intravenous infusion on day 1 | Drug: NP10679<br>* NP10679<br>|
| Experimental: NP10679 300 mg<br>NP10679 300 mg intravenous infusion on day 1 | Drug: NP10679<br>* NP10679<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. | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of parent drug | Cmax after administration. | 4 days |