Safety and Pharmacokinetics of NP10679 in Normal Healthy... | NCT03565861

Studies
Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers

NCT03565861

Sponsor

Neurop Inc.

Status

Completed

Last Update Posted

Mar 13, 2019Actual

Enrollment

48Actual

Phase

Phase 1

Conditions

Safety Issues

Interventions

Placebo
NP10679

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 6, 2018Actual

Primary Completion Date

Sep 2, 2018Actual

Completion Date

Oct 10, 2018Actual

First Submitted Date

May 29, 2018

First Submission Date that Met QC Criteria

Jun 11, 2018

First Posted Date

Jun 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2019

Last Update Posted Date

Mar 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This 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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo intravenous 30 minute infusion on day 1	Drug: Placebo
NP10679 5 mg	Experimental	NP10679 5 mg intravenous infusion on day 1	Drug: NP10679
NP10679 15 mg	Experimental	NP10679 15 mg intravenous infusion on day 1	Drug: NP10679
NP10679 50 mg	Experimental	NP10679 50 mg intravenous infusion on day 1	Drug: NP10679
NP10679 100 mg	Experimental	NP10679 100 mg intravenous infusion on day 1	Drug: NP10679
NP10679 200 mg	Experimental	NP10679 200 mg intravenous infusion on day 1	Drug: NP10679

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Intravenous vehicle	Placebo
NP10679

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse events as a measure of safety and tolerability	Observed side effects and alteration in laboratory values.	8 days

Secondary Outcomes

Measure	Description	Time Frame
Plasma concentration of parent drug	Cmax after administration.	4 days

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Zaczek, Ph.D.	Neurop Inc.	Study Chair
Paolo DePetrillo	Pharmaron CPC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pharmaron CPC		Baltimore	Maryland	21201	United States