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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-04

Study Completion Date

2019-10-10

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.

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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

Conditions

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Stroke, Ischemic Pain, Postoperative Substance Abuse Subarachnoid Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo intravenous infusion over 30 minutes, five days of once daily dosing

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo via 30 minute infusion once daily for 5 days

NP10679 25 mg

NP10679 25 mg intravenous infusion over 30 minutes, five days of once daily dosing

Group Type EXPERIMENTAL

NP10679

Intervention Type DRUG

NP10679 25 mg via 30 minute infusion once daily for 5 days

NP10679 50 mg

NP10679 50 mg intravenous infusion over 30 minutes, five days of once daily dosing

Group Type EXPERIMENTAL

NP10679

Intervention Type DRUG

NP10679 25 mg via 30 minute infusion once daily for 5 days

NP10679 100 mg

NP10679 100 mg intravenous infusion over 30 minutes, five days of once daily dosing

Group Type EXPERIMENTAL

NP10679

Intervention Type DRUG

NP10679 25 mg via 30 minute infusion once daily for 5 days

Interventions

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Placebo

Placebo via 30 minute infusion once daily for 5 days

Intervention Type DRUG

NP10679

NP10679 25 mg via 30 minute infusion once daily for 5 days

Intervention Type DRUG

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.