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

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

This multiple ascending dose 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: Pain, Postoperative; Subarachnoid Hemorrhage; Stroke, Ischemic; Substance Abuse
• Intervention / Treatment: Drug: Placebo; Drug: NP10679

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 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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo intravenous infusion over 30 minutes, five days of once daily dosing	Drug: Placebo; Placebo via 30 minute infusion once daily for 5 days
Experimental: NP10679 25 mg; NP10679 25 mg intravenous infusion over 30 minutes, five days of once daily dosing	Drug: NP10679; NP10679 25 mg via 30 minute infusion once daily for 5 days
Experimental: NP10679 50 mg; NP10679 50 mg intravenous infusion over 30 minutes, five days of once daily dosing	Drug: NP10679; NP10679 25 mg via 30 minute infusion once daily for 5 days
Experimental: NP10679 100 mg; NP10679 100 mg intravenous infusion over 30 minutes, five days of once daily dosing	Drug: NP10679; NP10679 25 mg via 30 minute infusion once daily for 5 days

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	Observed side effects and alteration in laboratory values	10 days
Plasma concentration of parent drug	Pharmacokinetic parameters during dosing period through 4 days post dosing	9 days

Collaborators and Investigators

• Sponsor: Neurop Inc.
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Pharmaron

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): October 10, 2019

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: NMDA; GluN2B
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Stroke; Intracranial Hemorrhages; Substance-Related Disorders; Pain, Postoperative; Ischemic Stroke; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: NP10679-002; 3R44NS071657-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No