Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers

Safety Issues Clinical Trial

Official title:

A Phase 1, Randomized , Double Blind, Single Ascending Dose Study to Investigate Safety, Tolerability and PK of NP10679 in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565861
• Other study ID #: NP10679-001
• Status: Completed
• Phase: Phase 1
• Start date: April 6, 2018
• Est. completion date: October 10, 2018

Study information

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

Clinical Trial Summary

This 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 10, 2018
• Est. primary completion date: September 2, 2018
• 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

• Safety Issues

Intervention

Drug:
• Placebo
Intravenous vehicle
• NP10679
NP10679

Locations

Country	Name	City	State
United States	Pharmaron CPC	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Neurop Inc.

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.	8 days
Secondary	Plasma concentration of parent drug	Cmax after administration.	4 days