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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04007263
• Other study ID #: NP10679-002
• Secondary ID: 3R44NS071657-06
• Status: Completed
• Phase: Phase 1
• Start date: April 4, 2019
• Est. completion date: October 10, 2019

Study information

• Verified date: July 2019
• Source: Neurop Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 10, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Pain, Postoperative
• Stroke, Ischemic
• Subarachnoid Hemorrhage
• Substance Abuse
• Substance-Related Disorders

Intervention

Drug:
• Placebo
Placebo via 30 minute infusion once daily for 5 days
• NP10679
NP10679 25 mg via 30 minute infusion once daily for 5 days

Locations

Country	Name	City	State
United States	Pharmaron CPC	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Neurop Inc.	National Institute of Neurological Disorders and Stroke (NINDS), Pharmaron

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events as a measure of safety and tolerability	Observed side effects and alteration in laboratory values	10 days
Primary	Plasma concentration of parent drug	Pharmacokinetic parameters during dosing period through 4 days post dosing	9 days