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

Phase 1

Completed

• Conditions: Stroke, Ischemic; Substance Abuse; Pain, Postoperative; Subarachnoid Hemorrhage
• Interventions: Drug: Placebo; Drug: NP10679

• Registration Number: NCT04007263
• Lead Sponsor: Neurop Inc.

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 Timeline

• Study Start: 2019-04-04
• Status Verified: 2019-07
• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-05
• Primary Completion: 2019-08-30
• Study Completion: 2019-10-10
• Last Update Submitted: 2019-11-01
• Last Update Posted: 2019-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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
Placebo	Placebo	Placebo intravenous infusion over 30 minutes, five days of once daily dosing
NP10679 25 mg	NP10679	NP10679 25 mg intravenous infusion over 30 minutes, five days of once daily dosing
NP10679 50 mg	NP10679	NP10679 50 mg intravenous infusion over 30 minutes, five days of once daily dosing
NP10679 100 mg	NP10679	NP10679 100 mg intravenous infusion over 30 minutes, five days of once daily dosing

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events as a measure of safety and tolerability	10 days	Observed side effects and alteration in laboratory values
Plasma concentration of parent drug	9 days	Pharmacokinetic parameters during dosing period through 4 days post dosing

Trial Locations

Locations (1)

Pharmaron CPC; 🇺🇸 Baltimore, Maryland, United States