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Study of Safety, Tolerability and Pharmacokinetics of NRX-1074 in Normal Healthy Volunteers

NCT02366364 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-02-22

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and tolerability of multiple oral (PO) ascending doses of NRX-1074 in normal healthy volunteers.

Conditions

Interventions

DRUG

Placebo

Single oral administration of placebo consumption on Day 1

DRUG

NRX-1074 375 mg

Single oral administration of 375 mg consumption on Day 1

DRUG

NRX-1074 500 mg

Single oral administration of 500 mg consumption on Day 1

DRUG

NRX-1074 750 mg

Single oral administration of 750 mg consumption on Day 1

Sponsors & Collaborators

  • Naurex, Inc, an affiliate of Allergan plc

    lead INDUSTRY

Principal Investigators

  • Mimi Van Der Leden, MD, PhD · Chicago Research Center, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

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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 NCT02366364 on ClinicalTrials.gov