NCT03780465

A Study of Safety and Tolerability of NOX66 in Healthy Volunteers

A Single Centre Study of Pharmacokinetics and Safety of NOX66 in Healthy Subjects

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Noxopharm Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study will be a single-centre study of NOX66 in two formulations administered once rectally and oral idronoxil . Approximately 50 subjects will be enrolled in 5 cohorts, comprising 1 oral dose (400 mg) and 4 NOX66 dose Cohorts (400 and 600 mg in formulation A and B). Eligible subjects will be admitted to the research clinic the day prior to dosing for baseline evaluations and will be fasted for a minimum of 10 hours prior to pre-dosing procedures. On treatment day, subjects will be administered NOX66 suppository as single dose or as oral suspension. Subjects remain in the clinic for 24 hours (h) after each dose for safety and pharmacokinetic assessments and return for 3 follow up visits. Ten subjects will be assigned to treatment dose Cohorts (1-5) and subjects within each of these cohorts will be randomised to either active or placebo (n=8 active; n= 2 placebo). For all dose cohorts, there will be two sentinel subjects (2 active) who will be dosed at a minimum 24 hours prior to remainder of the cohort who will be dosed simultaneously thereafter. Dose escalation of NOX66 dose cohorts to occur once safety and PK has been confirmed, by Data Safety Monitoring Board, in subjects in the prior cohort as applicable. Following interim review of accumulating PK data from first 3 cohorts, the Sponsor may modify subject numbers within a cohort or cohort dose levels and implemented following approval by IRB.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2018-12-19
• Last updated: 2019-05-28

Locations

1 site across 1 country: Australia