Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers

March 11, 2019 updated by: Neurop Inc.

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

This study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Pharmaron CPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo intravenous 30 minute infusion on day 1
Drug: Placebo
Intravenous vehicle
Experimental: NP10679 5 mg
NP10679 5 mg intravenous infusion on day 1
Drug: NP10679
NP10679
Experimental: NP10679 15 mg
NP10679 15 mg intravenous infusion on day 1
Drug: NP10679
NP10679
Experimental: NP10679 50 mg
NP10679 50 mg intravenous infusion on day 1
Drug: NP10679
NP10679
Experimental: NP10679 100 mg
NP10679 100 mg intravenous infusion on day 1
Drug: NP10679
NP10679
Experimental: NP10679 200 mg
NP10679 200 mg intravenous infusion on day 1
Drug: NP10679
NP10679
Experimental: NP10679 300 mg
NP10679 300 mg intravenous infusion on day 1
Drug: NP10679
NP10679

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events as a measure of safety and tolerability
Time Frame: 8 days
Observed side effects and alteration in laboratory values.
8 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurop Inc.

Investigators

  • Study Chair: Robert Zaczek, Ph.D., Neurop Inc.
  • Principal Investigator: Paolo DePetrillo, Pharmaron CPC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2018

Primary Completion (Actual)

September 2, 2018

Study Completion (Actual)

October 10, 2018

Study Registration Dates

First Submitted

May 29, 2018

First Submitted That Met QC Criteria

June 11, 2018

First Posted (Actual)

June 21, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • NP10679-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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