Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000833561p
Ethics application status
Submitted, not yet approved
Date submitted
5/06/2024
Date registered
5/07/2024
Date last updated
5/07/2024
Date data sharing statement initially provided
5/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1, Single Centre, Open Label, Single Dose, Food Effect, Cross Over Study to Investigate the Safety and Pharmacokinetics of Ziverdox in Healthy Volunteers
Scientific title
A Phase 1, Single Centre, Open Label, Single Dose, Food Effect, Cross Over Study to Investigate the Safety and Pharmacokinetics of Ziverdox in Healthy Volunteers
Secondary ID [1] 312263 0
Nil known
Universal Trial Number (UTN)
U1111-1307-7794
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 333981 0
Condition category
Condition code
Respiratory 330645 330645 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive a single oral dose of 1 tablet of 137mg Ziverdox under fasted conditions on Day 1 and under fed conditions on Day 15. Both doses of the study treatment will be given in the clinic under supervision to ensure compliance. The fasted conditions will be nil solids but water permitted for 8 hours prior to dose and no food for 4 hours post dose. The fed conditions will be that participants will have a high fat meal within 30 minutes of dosing.
Intervention code [1] 328722 0
Treatment: Drugs
Comparator / control treatment
All participants will receive Ziverdox. Participants will receive Ziverdox under fed or fasted conditions. The reference comparator will be the fasted group which will be compared with the fed group.
Control group
Active

Outcomes
Primary outcome [1] 338396 0
Safety and tolerability of Ziverdox under fed compared to fasted conditions
Timepoint [1] 338396 0
AEs and SAEs will be collected from screening throughout the study. Screening -Day 28 to Day 22
Safety Labs will be done on Screening (Day -28 to -2), Days 1, 2, 14, 16 & 22. Vital signs will be done from Screening and throughout the study.
Physical Exam will be done Screening Day-28 to -2, -1, 14 and 22.
Self Reported Events to be captured on Days -1 to 22.
Secondary outcome [1] 435758 0
PK of Ziverdox under fed compared to fasted conditions
Timepoint [1] 435758 0
PK samples will be taken on Day 1, within 90 mins prior to dosing and at 0.5 , 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 12 hours post dosing. Samples will also be taken on Day 2, at 24 and 36 hours post dose, on Day 3, 48 hours post dose, on Day 4, 72 hours post dose, then on Day 15, 90 mins prior to dosing, then after dosing at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8 and 12 hours post dose. Then on Day 16 at 24 and 36 hours post dose, on Day 17, 48 hours post dose and Day 18, 72 hours post dose.

Eligibility
Key inclusion criteria
1. Healthy Volunteers
2. Male or Female
3. BMI 18.0-35.0 kg/m2,
4. Weight >50kgs
5. HREC worded Contraception for both males and females. Including male partners.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Presence or history of any cardiovascular, gastrointestinal, renal, hepatic, respiratory, hematological, immunological, dermatological, neurological, or psychiatric/psychological condition, which is considered to be clinically significant by the investigator or delegate.
2. Any concomitant disease or condition that could interfere with the conduct of the study or that would, in the opinion of the investigator, pose an unacceptable risk to the participant.
3. Normal hematologic and hepatic function defined as liver function tests = 1.5 x upper limit of normal and estimated glomerular filtration rate > 59 and determined by clinical lab results. Repeat tests may be conducted at the discretion of the investigator.
4. Clinically relevant abnormal laboratory results, 12-lead electrocardiogram (ECG) and vital signs, or physical findings at screening and/or Day -1 as judged by the investigator. Tests performed during screening may be repeated once at the discretion of the investigator to confirm eligibility.
5. Use of prescription medication 14 days prior to dosing on Day 1 until the end of study (EOS) visit. Exceptions are hormone replacement therapy and contraception. Additional exceptions may apply on a case-by-case basis if considered not to interfere with the objectives of the study, at the discretion of the investigator and/or medical monitor.
6. Use of over-the-counter medications in the 7 days or 5 half-lives before dosing on Day 1 until the EOS visit. Exceptions are paracetamol (up to 2 gm/day) and vitamins. Additional exceptions may apply on a case-by-case basis if considered not to interfere with the objectives of the study, at the discretion of the investigator and/or medical monitor.
7. Active COVID-19 infection or COVID-19 infection within the last 3 months prior to screening. Long COVID-19 not resolved for longer than 3 months.
8. Treatment with an investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to screening.
9. Known allergy to the investigational product or any of its components.
10. Participants have donated or received any blood or blood products within 3 months prior to dosing.
11. Unwilling to abstain from grapefruit-containing foods or beverages or Seville orange-containing foods or beverages from 48 hours prior to investigational product administration and during the confinement periods.
12. Unwilling to refrain from alcohol consumption from 48 hours prior to investigational product administration and during the confinement periods.
13. Unwilling to refrain from consuming caffeine/xanthine beverages or food (tea, coffee, chocolate), from 48 hours prior to investigational product administration and during the confinement periods.
14. Unwilling to avoid heavy exercise (eg, marathon runners, weightlifters) from 48 hours prior to investigational product administration and during the confinement periods.
15. Unwilling to refrain from use of nicotine containing products from 48 hours prior to investigational product administration and during the confinement period/s. Products approved for smoking cessation such as nicotine patches, gum and lozenges may be allowed throughout the study at the investigator’s discretion.
16. Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the study or result in incomplete or poor-quality data.

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/07/2024
Actual
Date of last participant enrolment
Anticipated
29/07/2024
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 26738 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 42786 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 316648 0
Commercial sector/Industry
Name [1] 316648 0
Topelia Aust Ltd
Country [1] 316648 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Topelia Aust Ltd
Address
Country
Australia
Secondary sponsor category [1] 318833 0
None
Name [1] 318833 0
Address [1] 318833 0
Country [1] 318833 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315426 0
Bellberry Human Research Ethics Committee H
Ethics committee address [1] 315426 0
Ethics committee country [1] 315426 0
Australia
Date submitted for ethics approval [1] 315426 0
22/05/2024
Approval date [1] 315426 0
Ethics approval number [1] 315426 0

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

Contacts
Principal investigator
Name 134662 0
Dr Mohamed Bakra
Address 134662 0
CMAX Clinical Research. 21-24 North Terrace, Adelaide SA 5000
Country 134662 0
Australia
Phone 134662 0
+61870887900
Fax 134662 0
Email 134662 0
mohamed.bakra@cmax.com.au
Contact person for public queries
Name 134663 0
David Fox
Address 134663 0
Topelia Aust. 1/229 Great N Rd, Five Dock NSW 2046
Country 134663 0
Australia
Phone 134663 0
+61 498 807 203
Fax 134663 0
Email 134663 0
david@topeliaaustralia.com
Contact person for scientific queries
Name 134664 0
David Fox
Address 134664 0
Topelia Aust. 1/229 Great N Rd, Five Dock NSW 2046
Country 134664 0
Australia
Phone 134664 0
+61 498 807 203
Fax 134664 0
Email 134664 0
david@topeliaaustralia.com

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.