Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers

Phase 1

Completed

• Conditions: Safety Issues
• Interventions: Drug: NP10679; Drug: Placebo

• Registration Number: NCT03565861
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-04-06
• Study First Submitted: 2018-05-29
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-21
• Primary Completion: 2018-09-02
• Study Completion: 2018-10-10
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
NP10679 15 mg	NP10679	NP10679 15 mg intravenous infusion on day 1
NP10679 5 mg	NP10679	NP10679 5 mg intravenous infusion on day 1
NP10679 200 mg	NP10679	NP10679 200 mg intravenous infusion on day 1
NP10679 100 mg	NP10679	NP10679 100 mg intravenous infusion on day 1
Placebo	Placebo	Placebo intravenous 30 minute infusion on day 1
NP10679 50 mg	NP10679	NP10679 50 mg intravenous infusion on day 1
NP10679 300 mg	NP10679	NP10679 300 mg intravenous infusion on day 1

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Plasma concentration of parent drug	4 days	Cmax after administration.

Trial Locations

Locations (1)

Pharmaron CPC; 🇺🇸 Baltimore, Maryland, United States