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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04007263
Recruitment Status : Completed
First Posted : July 5, 2019
Last Update Posted : November 4, 2019
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Pharmaron
Information provided by (Responsible Party):
Neurop Inc.

Study Description
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Brief Summary:
This multiple ascending dose study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Pain, Postoperative Substance Abuse Subarachnoid Hemorrhage Drug: Placebo Drug: NP10679 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double Blind, Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of NP10679 in Healthy Adults"
Actual Study Start Date : April 4, 2019
Actual Primary Completion Date : August 30, 2019
Actual Study Completion Date : October 10, 2019
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04007263


Locations
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United States, Maryland
Pharmaron CPC
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Neurop Inc.
National Institute of Neurological Disorders and Stroke (NINDS)
Pharmaron
More Information
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Responsible Party: Neurop Inc.
ClinicalTrials.gov Identifier: NCT04007263    
Other Study ID Numbers: NP10679-002
3R44NS071657-06 ( U.S. NIH Grant/Contract )
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neurop Inc.:
NMDA
GluN2B
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Ischemic Stroke
Hemorrhage
Pain, Postoperative
Substance-Related Disorders
Pathologic Processes
Postoperative Complications
Pain
Neurologic Manifestations
Intracranial Hemorrhages
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Chemically-Induced Disorders
Mental Disorders
Stroke