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Trial registered on ANZCTR


Registration number
ACTRN12624001329550p
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] 313293 0
test
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
test 335617 0
Condition category
Condition code
Cancer 332183 332183 0 0
Bladder

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
test
Intervention code [1] 329867 0
Treatment: Drugs
Comparator / control treatment
test
Control group
Active

Outcomes
Primary outcome [1] 339781 0
test
Timepoint [1] 339781 0
test
Primary outcome [2] 339786 0
prim outcome 2
Timepoint [2] 339786 0
prim outcome timepoint 2
Secondary outcome [1] 441174 0
test
Timepoint [1] 441174 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
18/12/2024
Actual
Date of last participant enrolment
Anticipated
20/12/2024
Actual
Date of last data collection
Anticipated
22/12/2024
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 317743 0
Government body
Name [1] 317743 0
test gov body
Country [1] 317743 0
Australia
Primary sponsor type
Government body
Name
gov body test name
Address
Country
Australia
Secondary sponsor category [1] 320057 0
None
Name [1] 320057 0
Address [1] 320057 0
Country [1] 320057 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316435 0
test ethics committee.
Ethics committee address [1] 316435 0
Ethics committee country [1] 316435 0
Australia
Date submitted for ethics approval [1] 316435 0
13/12/2024
Approval date [1] 316435 0
Ethics approval number [1] 316435 0

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

Contacts
Principal investigator
Name 137878 0
Mr Geoffrey Hall
Address 137878 0
test
Country 137878 0
Australia
Phone 137878 0
+61 433245654
Fax 137878 0
Email 137878 0
[email protected]
Contact person for public queries
Name 137879 0
Geoffrey Hall
Address 137879 0
test
Country 137879 0
Australia
Phone 137879 0
+61 433245654
Fax 137879 0
Email 137879 0
[email protected]
Contact person for scientific queries
Name 137880 0
Geoffrey Hall
Address 137880 0
test
Country 137880 0
Australia
Phone 137880 0
+61 433245654
Fax 137880 0
Email 137880 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.