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NCT Number: NCT04007263

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

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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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chemically-Induced Disorders Hemorrhage Intracranial Hemorrhages Ischemic Stroke Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Stroke Subarachnoid Hemorrhage Substance Abuse Substance-Related Disorders Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaron CPC

Baltimore, Maryland, 21201, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Placebo via 30 minute infusion once daily for 5 days

NP10679

Drug

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

Primary outcomes

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

    Time frame: 10 days

    Observed side effects and alteration in laboratory values

  2. Plasma concentration of parent drug

    Time frame: 9 days

    Pharmacokinetic parameters during dosing period through 4 days post dosing

Sponsors and collaborators

Lead sponsor

Neurop Inc.

Industry

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Pharmaron

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 5, 2019
Registry last updated
Nov 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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