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

Primary Purpose

Stroke, Ischemic, Pain, Postoperative, Substance Abuse

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Placebo

NP10679

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring NMDA, GluN2B

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Pharmaron CPC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

NP10679 25 mg

NP10679 50 mg

NP10679 100 mg

Arm Description

Placebo intravenous infusion over 30 minutes, five days of once daily dosing

NP10679 25 mg intravenous infusion over 30 minutes, five days of once daily dosing

NP10679 50 mg intravenous infusion over 30 minutes, five days of once daily dosing

NP10679 100 mg intravenous infusion over 30 minutes, five days of once daily dosing

Outcomes

Primary Outcome Measures

Incidence of adverse events as a measure of safety and tolerability

Observed side effects and alteration in laboratory values

Plasma concentration of parent drug

Pharmacokinetic parameters during dosing period through 4 days post dosing

Secondary Outcome Measures

Full Information

NCT ID

NCT04007263

First Posted

July 1, 2019

Last Updated

November 1, 2019

Sponsor

Neurop Inc.

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04007263

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

April 4, 2019 (Actual)

Primary Completion Date

August 30, 2019 (Actual)

Study Completion Date

October 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Neurop Inc.

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Ischemic, Pain, Postoperative, Substance Abuse, Subarachnoid Hemorrhage

Keywords

NMDA, GluN2B

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo intravenous infusion over 30 minutes, five days of once daily dosing

Arm Title

NP10679 25 mg

Arm Type

Experimental

Arm Description

NP10679 25 mg intravenous infusion over 30 minutes, five days of once daily dosing

Arm Title

NP10679 50 mg

Arm Type

Experimental

Arm Description

NP10679 50 mg intravenous infusion over 30 minutes, five days of once daily dosing

Arm Title

NP10679 100 mg

Arm Type

Experimental

Arm Description

NP10679 100 mg intravenous infusion over 30 minutes, five days of once daily dosing

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo via 30 minute infusion once daily for 5 days

Intervention Type

Drug

Intervention Name(s)

NP10679

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of adverse events as a measure of safety and tolerability

Description

Observed side effects and alteration in laboratory values

Time Frame

10 days

Title

Plasma concentration of parent drug

Description

Pharmacokinetic parameters during dosing period through 4 days post dosing

Time Frame

9 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Pharmaron CPC

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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