MedTrace Logo

A Study of Safety and Tolerability of NOX66 in Healthy Volunteers

NCT03780465 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2019-05-28

No results posted yet for this study

Summary

A Phase 1, double- blinded, randomised, placebo-controlled study to assess safety, tolerability and pharmacokinetics of 2 formulations of NOX66 in healthy subjects when administered over 4 cohorts as single NOX66 dose of 400 mg and 600 mg in comparison to single oral dose of 400 mg idronoxil.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Oral idronoxil suspension

Idronoxil powder up to 150 ml ORA-BLEND® flavoured syrup

DRUG

NOX66 (A)

Idronoxil formulated in suppository base A

DRUG

NOX66 (B)

Idronoxil formulated in suppository base B

Sponsors & Collaborators

  • Noxopharm Limited

    lead INDUSTRY

Principal Investigators

  • Marinella Messina, PhD · Noxopharm Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2019-03-01
Completion
2019-03-01

Countries

  • Australia

Study Locations

More Related Trials

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 NCT03780465 on ClinicalTrials.gov