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

NCT04007263 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-11-04

No results posted yet for this study

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

Interventions

DRUG

Placebo

Placebo via 30 minute infusion once daily for 5 days

DRUG

NP10679

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

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Pharmaron

    collaborator INDUSTRY

  • Neurop Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-04
Primary Completion
2019-08-30
Completion
2019-10-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04007263 on ClinicalTrials.gov