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Trial registered on ANZCTR


Registration number
ACTRN12624001330538p
Ethics application status
Submitted, not yet approved
Date submitted
16/12/2024
Date registered
16/12/2024
Date last updated
16/12/2024
Date data sharing statement initially provided
16/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
test
Scientific title
test
Secondary ID [1] 313294 0
test
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
test 335618 0
Condition category
Condition code
Cancer 332184 332184 0 0
Bladder

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
test
Intervention code [1] 329868 0
Treatment: Drugs
Comparator / control treatment
test
Control group
Active

Outcomes
Primary outcome [1] 339782 0
test
Timepoint [1] 339782 0
test
Secondary outcome [1] 441175 0
test
Timepoint [1] 441175 0
test

Eligibility
Key inclusion criteria
test
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
test

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/12/2024
Actual
Date of last participant enrolment
Anticipated
18/12/2024
Actual
Date of last data collection
Anticipated
19/12/2024
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 317744 0
Government body
Name [1] 317744 0
test gov body 1
Country [1] 317744 0
Australia
Funding source category [2] 317747 0
Government body
Name [2] 317747 0
funding source name 2
Country [2] 317747 0
Australia
Primary sponsor type
Government body
Name
gov body test name
Address
Country
Australia
Secondary sponsor category [1] 320058 0
None
Name [1] 320058 0
Address [1] 320058 0
Country [1] 320058 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316436 0
test
Ethics committee address [1] 316436 0
Ethics committee country [1] 316436 0
Australia
Date submitted for ethics approval [1] 316436 0
13/12/2024
Approval date [1] 316436 0
Ethics approval number [1] 316436 0

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

Contacts
Principal investigator
Name 137882 0
Mr Geoffrey Hall
Address 137882 0
test
Country 137882 0
Australia
Phone 137882 0
+61 455123456
Fax 137882 0
Email 137882 0
[email protected]
Contact person for public queries
Name 137883 0
Geoffrey Hall
Address 137883 0
test
Country 137883 0
Australia
Phone 137883 0
+61 455123456
Fax 137883 0
Email 137883 0
[email protected]
Contact person for scientific queries
Name 137884 0
Geoffrey Hall
Address 137884 0
test
Country 137884 0
Australia
Phone 137884 0
+61 455123456
Fax 137884 0
Email 137884 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.