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CompletedNCT03565861Updated Mar 13, 2019

Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers

A Phase 1 interventional study of Placebo and NP10679 in Safety Issues, sponsored by Neurop Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-13.

Sponsored by Neurop Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Sep 2018, 8 years 1 month ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Safety Issues
03

In context

Lead sponsor

Neurop Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo intravenous 30 minute infusion on day 1

    Drug: Placebo

  • Experimental
    NP10679 5 mg

    NP10679 5 mg intravenous infusion on day 1

    Drug: NP10679

  • Experimental
    NP10679 15 mg

    NP10679 15 mg intravenous infusion on day 1

    Drug: NP10679

  • Experimental
    NP10679 50 mg

    NP10679 50 mg intravenous infusion on day 1

    Drug: NP10679

  • Experimental
    NP10679 100 mg

    NP10679 100 mg intravenous infusion on day 1

    Drug: NP10679

  • Experimental
    NP10679 200 mg

    NP10679 200 mg intravenous infusion on day 1

    Drug: NP10679

  • Experimental
    NP10679 300 mg

    NP10679 300 mg intravenous infusion on day 1

    Drug: NP10679

Interventions

  • DrugPlacebo

    Intravenous vehicle

  • DrugNP10679

    NP10679

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events as a measure of safety and tolerability

    Observed side effects and alteration in laboratory values.

    Time frame: 8 days

Secondary outcomes

  1. Plasma concentration of parent drug

    Cmax after administration.

    Time frame: 4 days

07

Study locations

1 site
  • Pharmaron CPC
    Baltimore, Maryland 21201, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03565861
Lead sponsor
Neurop Inc.
Responsible party
Sponsor
First posted
Jun 21, 2018
Start date
Apr 6, 2018
Primary completion
Sep 2, 2018
Completion
Oct 10, 2018
Last update
Mar 13, 2019

Study contacts

Robert Zaczek, Ph.D.
study chair · Neurop Inc.
Paolo DePetrillo
principal investigator · Pharmaron CPC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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Neurop Inc.

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