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

NCT04007263 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: NP10679-0023R44NS071657-06
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

NMDA; GluN2B

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events as a measure of safety and tolerability

  Observed side effects and alteration in laboratory values

  10 days

• Plasma concentration of parent drug

  Pharmacokinetic parameters during dosing period through 4 days post dosing

  9 days

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

NP10679 25 mg

EXPERIMENTAL

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

Drug: NP10679

NP10679 50 mg

EXPERIMENTAL

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

Drug: NP10679

NP10679 100 mg

EXPERIMENTAL

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

Drug: NP10679

Interventions

Placebo DRUG

Placebo via 30 minute infusion once daily for 5 days

Placebo

NP10679 DRUG

NP10679 25 mg via 30 minute infusion once daily for 5 days

NP10679 100 mg; NP10679 25 mg; NP10679 50 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Clinical laboratory values greater than or equal to 2 times the upper limit of normal.
• Recent history (within 2 yrs) or current tobacco use.

Sponsors & Collaborators

• Neurop Inc.: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Pharmaron: collaborator

Study Sites (1)

Pharmaron CPC

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Zaczek R, Traynelis SF, Dingledine R, Koszalka GW, Laskowitz DT. Phase 1 Clinical Results for NP10679, a pH-sensitive GluN2B-selective N-methyl-d-aspartate Receptor Inhibitor. Clin Pharmacol Drug Dev. 2023 Jul;12(7):706-717. doi: 10.1002/cpdd.1217. Epub 2023 Jan 15.

  PMID: 36642931 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Pain, Postoperative; Substance-Related Disorders; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Chemically-Induced Disorders; Mental Disorders; Intracranial Hemorrhages; Hemorrhage

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 5, 2019
• Study Start: April 4, 2019
• Primary Completion: August 30, 2019
• Study Completion: October 10, 2019
• Last Updated: November 4, 2019

Record last verified: 2019-07

Locations

US (1)