Trials / Completed
CompletedNCT03565861
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
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Neurop Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Intravenous vehicle |
| DRUG | NP10679 | NP10679 |
Timeline
- Start date
- 2018-04-06
- Primary completion
- 2018-09-02
- Completion
- 2018-10-10
- First posted
- 2018-06-21
- Last updated
- 2019-03-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03565861. Inclusion in this directory is not an endorsement.