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

NeurOp

Status and phase: Completed; Phase 1

Conditions: Subarachnoid Hemorrhage; Pain, Postoperative; Substance Abuse; Stroke, Ischemic

Treatments: Drug: Placebo; Drug: NP10679

Study type: Interventional

Funder types: Industry; Other; NIH

Identifiers

NCT04007263

3R44NS071657-06 (U.S. NIH Grant/Contract)

NP10679-002

Details and patient eligibility

About

This multiple ascending dose study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.

Full 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

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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24 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo intravenous infusion over 30 minutes, five days of once daily dosing

Treatment:

Drug: Placebo

NP10679 25 mg

Experimental group

Description:

NP10679 25 mg intravenous infusion over 30 minutes, five days of once daily dosing

Treatment:

Drug: NP10679

NP10679 50 mg

Experimental group

Description:

NP10679 50 mg intravenous infusion over 30 minutes, five days of once daily dosing

Treatment:

Drug: NP10679

NP10679 100 mg

Experimental group

Description:

NP10679 100 mg intravenous infusion over 30 minutes, five days of once daily dosing

Treatment:

Drug: NP10679