The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03780465




Registration number
NCT03780465
Ethics application status
Date submitted
5/12/2018
Date registered
17/12/2018
Date last updated
21/01/2019

Titles & IDs
Public title
A Study of Safety and Tolerability of NOX66 in Healthy Volunteers
Scientific title
A Single Centre Study of Pharmacokinetics and Safety of NOX66 in Healthy Subjects
Secondary ID [1] 0 0
NOX66-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Oral idronoxil suspension
Treatment: Drugs - NOX66 (A)
Treatment: Drugs - NOX66 (B)

Active Comparator: Oral idronoxil - 10 male and female subjects randomised to 400 mg active Oral idronoxil suspension or oral placebo suspension (n=8 active; n= 2 placebo).

Experimental: NOX66 400 mg - 10 male and female subjects randomised to 400 mg active NOX66 (A) suppository or 400 mg active NOX66 (B) suppository or suppository placebo (n=8 active; n= 2 placebo).

Experimental: NOX66 600 mg - 10 male and female subjects randomised to 600 mg active NOX66 (A) suppository or 600 mg active NOX66 (B) suppository or suppository placebo (n=8 active; n= 2 placebo).


Treatment: Drugs: Oral idronoxil suspension
Idronoxil powder up to 150 ml ORA-BLEND® flavoured syrup

Treatment: Drugs: NOX66 (A)
Idronoxil formulated in suppository base A

Treatment: Drugs: NOX66 (B)
Idronoxil formulated in suppository base B

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area Under the concentration-time Curve for idronoxil from NOX66 and oral formulations - AUC will be determined form blood plasma and urine taken at pre-dose and post dose time points..
Plasma concentration data for idronoxil will be summarised for the PK population by treatment and scheduled sampling time.
Timepoint [1] 0 0
Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose
Primary outcome [2] 0 0
Maximal observed concentration for idronoxil levels from NOX66 and oral formulations - Maximal observed concentration of idronoxil will be assessed from blood plasma taken at pre-dose and post dose time points .
Timepoint [2] 0 0
Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose
Primary outcome [3] 0 0
Time to reach maximum observed concentration from idronoxil for NOX66 formulations and oral - Time to occurrence of maximum observed concentration will be measured from blood plasma taken at pre-dose and post dose time points.
Timepoint [3] 0 0
Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose
Primary outcome [4] 0 0
Terminal half-life of Plasma and Urine idronoxil from NOX66 and oral formulations and oral - Apparent terminal half-life will be assessed from blood plasma and urine taken at pre-dose and post dose time points.
Timepoint [4] 0 0
Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose.
Primary outcome [5] 0 0
Total body clearance of idronoxil after administration of NOX66 and oral formulations - Total body clearance will be assessed from blood plasma and urine taken at pre-dose and post dose time points.
Timepoint [5] 0 0
Day 1 pre-dose and at multiple time points (up to 144 hours) post-dose
Secondary outcome [1] 0 0
Number of subjects with treatment-related adverse events - Safety and tolerability of single doses of NOX66 formulations by assessing adverse events according to CTCAE version 5.0
Timepoint [1] 0 0
From screening up to end of study (144 hours)
Secondary outcome [2] 0 0
Relative bioavailability of NOX66 formulations compared to the oral idronoxil - To compare area under the concentration curve (AUC) of idronoxil from NOX66 to orally administered idronoxil.
Timepoint [2] 0 0
From pre-dose up to end of study (144 hours)
Secondary outcome [3] 0 0
Number subjects with clinical significant ECGs - Continuous cardiac monitoring by telemetry Holter device for oral dose cohort 1 and highest NOX66 dose cohorts (4 and 5) and safety ECGs for all dose cohorts.
Timepoint [3] 0 0
Telemetry 10 hours prior dosing continuously for 24 hours post dosing (cohorts 1, 4 and 5); safety ECGs for all cohorts pre dose and post dose to 144 hrs or end of study.
Secondary outcome [4] 0 0
Number subjects with clinical significant abnormalities in lab tests - Routine safety labs for all cohorts
Timepoint [4] 0 0
Screening to 7 days
Secondary outcome [5] 0 0
Number subjects with clinical significant abnormalities in vital signs - Routine vital signs for all cohorts
Timepoint [5] 0 0
Screening to 7 days

Eligibility
Key inclusion criteria
1. Provision of informed consent.

2. Male and/or female subjects, 18 - 55 years of age.

3. BMI of 17.5 to 30 kg/m2 and a total body weight >50 kg.

4. Negative hepatitis panel (including HBsAg and anti-HCV) and negative HIV antibody
screens.

5. Negative test for selected drugs of abuse.

6. Males and females of childbearing potential who are not abstinent from heterosexual
intercourse as part of their usual and preferred lifestyle must agree for the study
duration and for 3 months after study to use two effective means of contraception
(hormonal contraception, intrauterine device, condoms). Surgical sterilisation >3
months prior to Screening is acceptable.

- Postmenopausal females should have menopause confirmed by follicle-stimulating
hormone (FSH) testing.

- Subjects who have same sex partners or who practice abstinence in line with
standard and preferred lifestyle will not be required to use contraception.
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated asymptomatic,
penicillin, seasonal allergies at the time of dosing).

2. 12-lead ECG at screening or at first admission to the study center. Subjects with a
QTcF interval >450 msec or QRS interval =110 msec will be excluded.

3. Treatment with an investigational drug /device within 30 days (or as determined by the
local requirement) or 5 half-lives preceding the first dose of study medication
(whichever is longer).

4. Other severe acute or chronic medical or psychiatric conditions or a laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgement of the principal investigator (PI), would make the
subject inappropriate for entry into this study.

5. Abnormal nutritional status, including unconventional and abnormal dietary habits;
excessive or unusual vitamin intake; malabsorption (oral cohort only).

6. Has history of significant drug or alcohol abuse within past 5 years or has a positive
drug screen.

7. Smoking or use of nicotine-containing substances within past 2 months with the
exception for social smokers who will be allowed a maximum of 5 cigarettes per week.

8. Has use of any prescription or nonprescription medications or herbal supplements,
except for paracetamol, within 14 days before the first dose of study drug, unless
approved by the PI and sponsor.

9. History of stomach or intestinal surgery or resection that would potentially alter
absorption and/or excretion of orally administered drugs except that appendectomy,
cholecystectomy, and hernia repair will be allowed.

10. Consumption of grapefruit/starfruit-containing foods and beverages or other CYP3A4
inhibitors or inducers for 72 hours prior to Screening and during the entire study.

11. Donation of blood from 30 days prior to Screening through Study Completion/End of
treatment (ET), inclusive, or plasma from 2 weeks prior to Screening through Study
Completion/ET, inclusive.

12. Any acute or chronic condition that, in the opinion of the Investigator, would limit
the subject's ability to complete and/or participate in this clinical study.

13. Use of alcohol within previous 24 hours or use of caffeine within previous 12 hours of
Day -1 admission.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Noxopharm Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT03780465
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marinella Messina, PhD
Address 0 0
Noxopharm Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jason Lickliter
Address 0 0
Country 0 0
Phone 0 0
+61 3 9076 8960
Fax 0 0
Email 0 0
j.lickliter@nucleusnetwork.com.au
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable