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Safety Study of NNZ-2566 in Healthy Subjects, Following Oral Administration

NCT01420042 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-11-22

No results posted yet for this study

Summary

The purpose of this study is to obtain evidence of safety and determine the pharmacokinetics (PK) of NNZ-2566 in healthy volunteers, when administered orally.

Conditions

  • Brain Injuries, Traumatic

Interventions

DRUG

NNZ-2566

Glycyl-L-2-Methylprolyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with lemon flavoured cordial and Water for Injection.

DRUG

Placebo

Lemon flavoured cordial and Water for Injection

Sponsors & Collaborators

  • Neuren Pharmaceuticals Limited

    lead INDUSTRY

Principal Investigators

  • Maggie Scott · Neuren Pharmaceuticals Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-08-31
Completion
2012-09-30

Countries

  • Australia

Study Locations

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Entities

Drugs

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 NCT01420042 on ClinicalTrials.gov