Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000284763p
Ethics application status
Submitted, not yet approved
Date submitted
31/01/2022
Date registered
15/02/2022
Date last updated
15/02/2022
Date data sharing statement initially provided
15/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1/Part A study of the pharmacokinetics and safety of three doses of Virofonol (polyphenol rich sugar cane extract).
Scientific title
A Phase 1/Part A Study of the Pharmacokinetics and Dose Finding of Virofonol (polyphenol rich sugar cane extract) in Healthy Volunteers.
Secondary ID [1] 306289 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 325049 0
Condition category
Condition code
Infection 322485 322485 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Virofonol (the name for the pharmaceutical form of Polynol) capsules containing 250mg of the polyphenol rich sugar cane extract will be used for the study. The extract is Virofonol (the name for the pharmaceutical form of Polynol) capsules containing 250mg of the polyphenol rich sugar cane extract will be used for the study. The extract is a brown powder produced by spray drying the aqueous extract. There are no excipients in the capsule.
Virofonol contains a number of polyphenols and melanoidins. There is considerable literature on the antiviral and antibacterial properties of polyphenols.

Part A of this study will be performed in Australia. Part A of this study will investigate the pharmacokinetics of the main polyphenol constituents of Virofonol in healthy volunteers and assist in choosing the dose and frequency of administration of Virofonol.

Doses of 500mg, 750mg and 1000mg as a single dose will be administered orally in Part A of the study. Healthy volunteers aged between 18 and 55 years will be screened. Volunteers will be screened up to 28 days before enrolment.

Eligible patients will be identified by the investigator based on the physical examination, vital signs, laboratory parameters and Inclusion Criteria. On the day of admission (Day -1), volunteers will be admitted and have baseline tests performed to re-affirm their eligibility. The next day, on the morning of Day 1, the study dose will be administered and blood drawn at the required times (+/- 3 minutes). Volunteers will remain in the clinic overnight and then be discharged from the clinic on Day 2, after a blood draw collection 24 hours after the dose administration. A follow up phone call will be made 7 days (± 2days) after dosing to enquire about wellbeing and adverse events.

Each dose group will enrol a separate cohort of participants. Following completion of each cohort, all available safety data will be reviewed by the Safety Review Committee prior to commencing the next dose.

The 500mg dose group will be dosed first, then the 750mg group and then the 1000mg dose group sequentially following safety review by the Safety Review Committee (SRC).

Intervention code [1] 322720 0
Treatment: Drugs
Comparator / control treatment
No Control Group is used for Part A.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330267 0
Establish the pharmacokinetic profile of Virofonol administered orally to healthy volunteers. The following PK parameters will be examined: Peak plasma concentration (Cmax) and Time to peak plasma concentration (Tmax) obtained from the plasma concentration data; Elimination half life (t1/2); Area under the concentration time curve from time 0 to the last point evaluated (AUC0-t); Area under the concentration time curve from time 0 and extrapolated to infinity; Volume of Distribution; Clearance.
Timepoint [1] 330267 0
Blood samples collected at pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 9, 12 and 24 hours post-dose.
Primary outcome [2] 330269 0
Establish the safety of the selected doses following assessment of safety laboratory data, vital signs (including temperature, blood pressure, respiratory rate and heart rate), 12-Lead ECG, physical examinations and any treatment-emergent adverse events.

Temperature will be assessed using a tympanic thermometer.
Blood pressure will be assessed using a sphygmomanometer.
Respiratory rate (RR) will be assessed manually by observing subject at rest. RR will be determined by observing the rise of the subject chest, where one rise and one fall is equal to one respiration. The RR are taken for a 30 second period of time and the value doubled to calculate the subject breath per minutes.
Heart rate is measured using an automated vital signs machine
Timepoint [2] 330269 0
Treatment-emergent adverse events (TEAEs) will be collected from first day of dosing (Day 1) to Day 7 post-dose.
Vital signs, 12-lead ECGs, safety laboratory haematology and biochemistry will be collected at Screening (Day -28 to Day -2), Day 1 pre dose (and on Day 1 at 1hr, 2hr and 4hr post-dose for vital signs) and Day 2.
Secondary outcome [1] 405541 0
Not applicable
Timepoint [1] 405541 0
Not applicable

Eligibility
Key inclusion criteria
1. Age 18 to 55 years (inclusive at screening), BMI 18.0 to 32.0 kg/m2 who have given written informed consent.

2. Non-smoker or “light smokers” (less than or equal to 10 cigarettes or equivalent [e-cigarettes and marijuana] a week). Volunteers must agree to abstain from smoking whilst confine in the clinic

3. No clinically significant abnormalities (in the opinion of the Investigator) at the screening visit and prior to dosing.

4. Female volunteers of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at baseline.

5. Female volunteers must:
a. Be of nonchildbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before screening) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause, and a follicle stimulating hormone level > 40 IU/L at the screening visit), or
b. If women of childbearing potential (WOCBP), they must agree to be on hormonal contraception for at least 1 month prior to screening, not to donate ova, not to attempt to become pregnant and, if not exclusively in same-sex relationships, if engaging in sexual intercourse with a non-sterile male partner, must agree to use a highly effective method of contraception and the male partner wear a condom, from signing the consent form until at least 30 days after the dose of the study drug.

6. Male volunteers must:
a. Agree to use a condom when engaging in sexual intercourse with a WOCBP, a woman of nonchildbearing potential (WNOCBP), or a male partner. In addition, the participant’s female partner if a WOCBP, she must use one of the listed forms of highly effective methods of contraception from signing the consent form until at least 90 days after the dose of study drug.
b. Agree not to donate sperm from signing the consent form until at least 90 days after the dose of study drug.
Volunteers must have negative test result to Drugs of Abuse and Alcohol breath test at Screening and Admission (Day -1).

7. Have suitable venous access for blood sampling.

8. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

9. Volunteers with non-invasive skin cancers (BCC or SCC) or who have had a fully resected BCC or SCC may participate at the discretion of the PI.

10. Volunteers must agree to restrict their intake of polyphenols for 2 days before admission (Day -1) and during study dosing and blood draws. The main food and drinks to restrict are citrus products particularly orange juice and tea and coffee.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Serious or unstable medical or psychiatric condition that would prevent the participant from providing informed consent with the exception of mild depression and anxiety

2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, GI, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the past 3 months determined by the PI to be clinically significant

3. Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medications

4. Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma)

5. Any surgical procedures requiring general anaesthesia within 1 month prior to screening or planned surgery during the study

6. For WOCBP, a positive serum pregnancy test at the screening visit or a positive urine pregnancy test (with confirmatory serum pregnancy test) at Admission (Day -1).

7. Females who are breastfeeding or planning to breast feed at any time during the study

8. Positive test results of active human immunodeficiency virus (HIV) or hepatitis B surface antigen (HBsAg) antibodies at the screening visit. If subjects are HCV antibody positive, but PCR negative, they may be enrolled as this is assumed to be a cure of HCV.

9. History of substance abuse or alcohol abuse (defined as more than 13 to 14 standard drinks per week or regularly consuming more than 4 standard drinks on any one day; where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc./Vol], 100 mL wine [12% Alc./Vol], 30 mL spirit [40% Alc./Vol]) within 12 weeks prior to the screening visit.

10. Use of any prescription or over-the-counter medication (including herbal products, diet aids, and hormone supplements) within 10 days prior to the first study drug administration. Exceptions include: use of contraceptives; occasional use of paracetamol (doses of 500 mg up to every 6 hours or 2 g per day maximum for no more than 3 consecutive days); ibuprofen (doses of 400 mg up to every 6 hours or 1.6 g per day maximum for no more than 3 consecutive days); topical ointments, vitamins or dietary supplements, and any medication that, in the opinion of the Sponsor and the PI, would not be anticipated to impact the objectives of the study.

11. Use of any vaccinations within 14 days prior to the first study drug administration. Exception include: COVID-19 vaccination or booster is allowed up to 7 days prior to study drug administration.

12. Treatment with an investigational drug in another clinical trial within 30 days or 5 half-lives (whichever is longer) prior to the first administration of study drug in this trial

13. Any other condition or prior therapy that in the opinion of the Investigator would make the volunteer unsuitable for this study, including an inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/03/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310637 0
Commercial sector/Industry
Name [1] 310637 0
The Product Makers (TPM)
Country [1] 310637 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
The Product Makers (TPM)
Address
50 - 60 Popes Road,
Keysborough,
Victoria 3173
Country
Australia
Secondary sponsor category [1] 311849 0
None
Name [1] 311849 0
Address [1] 311849 0
Country [1] 311849 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310238 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 310238 0
Ethics committee country [1] 310238 0
Australia
Date submitted for ethics approval [1] 310238 0
08/12/2021
Approval date [1] 310238 0
Ethics approval number [1] 310238 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116958 0
Dr Philip Ryan
Address 116958 0
Nucleus Network Pty Ltd,
Level 5, Burnet Tower,
89 Commercial Rd,
Melbourne 3004, Victoria
Country 116958 0
Australia
Phone 116958 0
+61 3 8593 9800
Fax 116958 0
Email 116958 0
[email protected]
Contact person for public queries
Name 116959 0
Nucleus Network Melbourne
Address 116959 0
Nucleus Network Pty Ltd,
Level 5, Burnet Tower,
89 Commercial Rd,
Melbourne 3004, Victoria
Country 116959 0
Australia
Phone 116959 0
+61 1800 243 733
Fax 116959 0
Email 116959 0
[email protected]
Contact person for scientific queries
Name 116960 0
David Kingston
Address 116960 0
The Product Makers
50 - 60 Popes Road,
Keysborough,
Victoria 3173
Country 116960 0
Australia
Phone 116960 0
+61 0408 444 814
Fax 116960 0
Email 116960 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.