Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03565861

Enrollment

Registered

2018-06-21

Start date

2018-04-06

Completion date

2018-10-10

Last updated

2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety Issues

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.

Interventions

DRUGPlacebo

Intravenous vehicle

DRUGNP10679

NP10679

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Adaptive design of placebo and up to six escalating doses of NP10679

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026