Trial | NCT03565861  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    Safety Issues

  • Intervention/Treatment

    NP10679 ...

  • Study Participants

    48
This study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.
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.
Study Started
Apr 06
2018
Primary Completion
Sep 02
2018
Study Completion
Oct 10
2018
Last Update
Mar 13
2019

Drug Placebo

Intravenous vehicle

Drug NP10679

NP10679

Placebo Placebo Comparator

Placebo intravenous 30 minute infusion on day 1

NP10679 5 mg Experimental

NP10679 5 mg intravenous infusion on day 1

NP10679 15 mg Experimental

NP10679 15 mg intravenous infusion on day 1

NP10679 50 mg Experimental

NP10679 50 mg intravenous infusion on day 1

NP10679 100 mg Experimental

NP10679 100 mg intravenous infusion on day 1

NP10679 200 mg Experimental

NP10679 200 mg intravenous infusion on day 1

NP10679 300 mg Experimental

NP10679 300 mg intravenous infusion on day 1

Criteria 

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.
No Results Posted