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Trial registered on ANZCTR


Registration number
ACTRN12624001328561
Ethics application status
Approved
Date submitted
15/10/2024
Date registered
1/11/2024
Date last updated
1/11/2024
Date data sharing statement initially provided
1/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative assessment of the absorption of a 53858-86-9 tablet against an innovator product conducted in participants under fed conditions with diet control.
Scientific title
A single dose, double-blind, randomized bioavailability study of a test formulation of 53858-86-9 tablet in a 2 way crossover comparison against the innovator 53858-86-9 tablet conducted in participants under fed conditions with diet control.
Secondary ID [1] 313155 0
None
Universal Trial Number (UTN)
U1111-1312-5538
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low ferritin 335431 0
Condition category
Condition code
Blood 331989 331989 0 0
Anaemia
Diet and Nutrition 331992 331992 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single dose, crossover study design whereby each participant receives the test formulation of 53858-86-9 370 mg tablet on one occasion and the innovator formulation of 53858-86-9 370 mg tablet on one occasion with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of 53858-86-9.

The duration of the study is approximately 5 weeks comprising up to 3 weeks for screening, two 2-day sampling periods, a minimum of 1 week washout and 1 day study exit procedures. Screening and study exit procedures will take place at an outpatient facility and each clinical period will involve confinement at the Clinical Site.

Participants will be required to consume a controlled diet throughout both study periods. All food will be supplied for consumption at home and at the clinical site. Breakfast will be consumed at the Clinical Site prior to dosing in both study periods. The diet will consist of daily intake of protein: 122.9; fat: 81g; carbs: 243.6g; iron: 8.8mg. This is approximate only and may vary slightly each day.

Each dose will be taken orally with 240 ml of water at ambient temperature immediately following a standardised breakfast. Medication must be swallowed whole and a mouth check will be conducted to ensure the medication has been taken as directed.
Intervention code [1] 329722 0
Treatment: Drugs
Comparator / control treatment
The comparator/control for this trial is the innovator formulation of 53858-86-9.
Control group
Active

Outcomes
Primary outcome [1] 339591 0
To compare the bioavailability of 53858-86-9 (as summarised by Cmax and AUC) for the formulation.
Timepoint [1] 339591 0
Blood samples will be collected at -2, -0.5, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, 22 and 24 hours post dosing.
Secondary outcome [1] 440536 0
Time to maximum peak concentration (Tmax) will be determined by serum sample analysis.
Timepoint [1] 440536 0
blood samples will be collected at -2, -0.5, 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, 20, 22 and 24 hours post dosing.

Eligibility
Key inclusion criteria
Participants presenting with low ferritin, normal haemoglobin
Aged between 18 and 55
Non-smoker
BMI between 18.5 and 32.0 inclusive
Able to consume a controlled diet
Healthy individuals as determined by medical history, physical examination, electrocardiogram (ECG), blood pressure and laboratory tests
Able to provide written informed consent
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches
Any history of haemochromatosis.
An expectation of menstruation during the dose administration and sample collection periods
Concomitant drug therapy of any kind
Sensitivity to 53858-86-9 or any other similar class of medicines, or any excipients in either formulation.
History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
Smoker (anyone who has smoked in the last 6 months)
History of alcohol or drug abuse or dependency
Difficulty with swallowing whole tablets or poor venous access
Participation in a drug study within 30 days of the start of the study or donated blood in the 30 days preceding the study.
Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk

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)
All formulations will be labelled as Formulation A and B. The identification of each treatment will only be known to the Managing Director, the Section Head - Trials and Regulatory Affairs or their delegates. The Trial Physician and Principal Investigator are completely blinded and do not know what treatments are allocated to each subject who has been deemed eligible for participation. Allocation concealment to each formulation is completed by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participant will be identified by a 3 digit screening number and a 2 digit subject number. The screening number will be issued once the participant has given written consent to participate in the study and the two digit subject number (randomisation number) after acceptance into the study. Allocation of the subject number is completed by simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 26626 0
New Zealand
State/province [1] 26626 0
Otago

Funding & Sponsors
Funding source category [1] 317597 0
Commercial sector/Industry
Name [1] 317597 0
Maple Healthcare Pty Ltd
Country [1] 317597 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Zenith Technology Corporation Limited
Address
Country
New Zealand
Secondary sponsor category [1] 319905 0
None
Name [1] 319905 0
Address [1] 319905 0
Country [1] 319905 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316302 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 316302 0
https://ethics.health.govt.nz/about/northern-a-health-and-disability-ethics-committee/
Ethics committee country [1] 316302 0
New Zealand
Date submitted for ethics approval [1] 316302 0
05/09/2024
Approval date [1] 316302 0
23/09/2024
Ethics approval number [1] 316302 0
2024 FULL 21219

Summary
Brief summary
The objective of this study is to compare the pharmacokinetic parameters of the test (new) formulation of 53858-86-9 tablet in a 2 way crossover comparison against the innovator 53858-86-9 tablet conducted in participants under fed conditions with diet control.
In lay terms the purpose of our study is to compare how two formulations of 53858-86-9 are handled in the body after taking a test and reference (innovator) tablet on one occasion each after consuming a high fat/low iron breakfast and having a controlled diet throughout the entire study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137454 0
Dr Noelyn Hung
Address 137454 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 137454 0
New Zealand
Phone 137454 0
+64 21 482 148
Fax 137454 0
Email 137454 0
[email protected]
Contact person for public queries
Name 137455 0
Linda Folland
Address 137455 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 137455 0
New Zealand
Phone 137455 0
+64 3 477 9669
Fax 137455 0
Email 137455 0
[email protected]
Contact person for scientific queries
Name 137456 0
Tak Hung
Address 137456 0
Zenith Technology Corporation Limited 156 Frederick Street (PO Box 1777) Dunedin 9016
Country 137456 0
New Zealand
Phone 137456 0
+64 3 477 9669
Fax 137456 0
Email 137456 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
All data will be compiled into a final report that is the property of the sponsor company. All participant data will be provided in summary format and result of the study only will be reported.


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.