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Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03565861
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Neurop Inc.

Brief Summary:
This 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
Safety Issues 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 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Adaptive design of placebo and up to six escalating doses of NP10679
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized , Double Blind, Single Ascending Dose Study to Investigate Safety, Tolerability and PK of NP10679 in Healthy Adults
Actual Study Start Date : April 6, 2018
Estimated Primary Completion Date : September 2, 2018
Estimated Study Completion Date : October 10, 2018

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo intravenous 30 minute infusion on day 1
Drug: Placebo
Intravenous vehicle

Experimental: NP10679 5 mg
NP10679 5 mg intravenous infusion on day 1
Drug: NP10679
NP10679

Experimental: NP10679 15 mg
NP10679 15 mg intravenous infusion on day 1
Drug: NP10679
NP10679

Experimental: NP10679 50 mg
NP10679 50 mg intravenous infusion on day 1
Drug: NP10679
NP10679

Experimental: NP10679 100 mg
NP10679 100 mg intravenous infusion on day 1
Drug: NP10679
NP10679

Experimental: NP10679 200 mg
NP10679 200 mg intravenous infusion on day 1
Drug: NP10679
NP10679

Experimental: NP10679 300 mg
NP10679 300 mg intravenous infusion on day 1
Drug: NP10679
NP10679




Primary Outcome Measures :
  1. Incidence of adverse events as a measure of safety and tolerability [ Time Frame: 8 days ]
    Observed side effects and alteration in laboratory values.


Secondary Outcome Measures :
  1. Plasma concentration of parent drug [ Time Frame: 4 days ]
    Cmax after administration.



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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.

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): NCT03565861


Contacts
Contact: Robert Zaczek, Ph.D. 860-853-0427 rzaczek@neuropinc.com
Contact: Ana Robertson 401-706-8762 Ana.Robertson@pharmaron-us.com

Locations
United States, Maryland
Pharmaron CPC Recruiting
Baltimore, Maryland, United States, 21201
Contact: Ana Robertson    410-706-8762    Ana.Robertson@pharmaron-us.com   
Sponsors and Collaborators
Neurop Inc.
Investigators
Study Chair: Robert Zaczek, Ph.D. Neurop Inc.
Principal Investigator: Paolo DePetrillo Pharmaron CPC

Responsible Party: Neurop Inc.
ClinicalTrials.gov Identifier: NCT03565861     History of Changes
Other Study ID Numbers: NP10679-001
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No