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出境医 / 临床实验 / A Multiple Ascending Dose Study of Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers

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

Study Description
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
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
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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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

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
Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date November 4, 2019
Actual Study Start Date  ICMJE April 4, 2019
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • Incidence of adverse events as a measure of safety and tolerability [ Time Frame: 10 days ]
    Observed side effects and alteration in laboratory values
  • Plasma concentration of parent drug [ Time Frame: 9 days ]
    Pharmacokinetic parameters during dosing period through 4 days post dosing
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multiple Ascending Dose Study of Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers
Official Title  ICMJE A Phase 1, Randomized, Double Blind, Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of NP10679 in Healthy Adults"
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke, Ischemic
  • Pain, Postoperative
  • Substance Abuse
  • Subarachnoid Hemorrhage
Intervention  ICMJE
  • Drug: Placebo
    Placebo via 30 minute infusion once daily for 5 days
  • Drug: NP10679
    NP10679 25 mg via 30 minute infusion once daily for 5 days
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo intravenous infusion over 30 minutes, five days of once daily dosing
    Intervention: Drug: Placebo
  • Experimental: NP10679 25 mg
    NP10679 25 mg intravenous infusion over 30 minutes, five days of once daily dosing
    Intervention: Drug: NP10679
  • Experimental: NP10679 50 mg
    NP10679 50 mg intravenous infusion over 30 minutes, five days of once daily dosing
    Intervention: Drug: NP10679
  • Experimental: NP10679 100 mg
    NP10679 100 mg intravenous infusion over 30 minutes, five days of once daily dosing
    Intervention: Drug: NP10679
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2019) 		24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 10, 2019
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04007263
Other Study ID Numbers  ICMJE NP10679-002
3R44NS071657-06 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Neurop Inc.
Study Sponsor  ICMJE Neurop Inc.
Collaborators  ICMJE
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • Pharmaron
Investigators  ICMJE Not Provided
PRS Account Neurop Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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