Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000782639
Ethics application status
Approved
Date submitted
7/12/2005
Date registered
7/12/2005
Date last updated
16/08/2022
Date data sharing statement initially provided
16/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A phase I study to assess the pharmacokinetics of a single dose of a slow-release solid injection of EPT1647 in healthy male volunteers
Scientific title
A phase I study to assess the pharmacokinetics of a single dose of a slow-release solid injection of EPT1647 in healthy male volunteers
Secondary ID [1] 224 0
Epitan Ltd: EP006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
N/A 938 0
Healthy male volunteers 939 0
Condition category
Condition code
Other 1008 1008 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
EPT1647 is a derivative of MSH which has been shown to increase eumelanin levels in humans. This study will evaluate the safety and pharmacokinetic profiles of a new formulation of EPT1647 over 30 days.
Intervention code [1] 790 0
Treatment: Drugs
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1347 0
To determine the pharmacokinetics of a new slow-release solid dose injectable form of EPT1647 administered subcutaneously to healthy men.
Timepoint [1] 1347 0
Measured prior to administration of EPT1647, 4, 8 and 12 hours after administration of EPT1647 on day 1, then at days 2, 3, 4, 5, 6, 8, 10, 12, 15 and 30.
Secondary outcome [1] 2398 0
To Determine the safety profile of a new slow relase solid dose injectable form of EPT1647 administered subcutaneously to healthy men.
Timepoint [1] 2398 0

Eligibility
Key inclusion criteria
* Healthy caucasian * No history of Melanoma includinjg in a first degree relative* No significant medical history or disorder* Take precautions to prevent pregnancy during and upto 3 months after study.* No history of drug or alcohol abuse.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/01/2006
Actual
10/01/2006
Date of last participant enrolment
Anticipated
Actual
22/02/2006
Date of last data collection
Anticipated
Actual
27/07/2006
Sample size
Target
6
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 1113 0
Commercial sector/Industry
Name [1] 1113 0
Epitan Limited
Country [1] 1113 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Epitan Limited
Address
Level 13, 1 Collins Street
Melbourne, VIC, 3000
AUSTRALIA
Country
Australia
Secondary sponsor category [1] 972 0
None
Name [1] 972 0
N/A
Address [1] 972 0
Country [1] 972 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2421 0
Centre for Pharmaceutical Research-University of South Australia
Ethics committee address [1] 2421 0
University of South Australia
Human Research Ethics Committee
General Purpose Building, Room 2-09
Mawson Lakes Campus
Mawson Lakes SA 5095
Ethics committee country [1] 2421 0
Australia
Date submitted for ethics approval [1] 2421 0
Approval date [1] 2421 0
26/10/2005
Ethics approval number [1] 2421 0

Summary
Brief summary
To determine how a new implant design of EPT1647 works in the body and to review any side effects that may occur.
Trial website
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 35409 0
A/Prof Robert Milne
Address 35409 0
Centre for Pharmaceutical Research Clinical Trials Unit, Sansom Institute University of South Australia Level 4 Reid Building, Frome Road Adelaide, SA, 5000
Country 35409 0
Australia
Phone 35409 0
+61 3 9660 4900
Fax 35409 0
Email 35409 0
[email protected]
Contact person for public queries
Name 9979 0
Deb Shaw
Address 9979 0
Centre for Pharmaceutical Research
School of Pharmacy and Medical Sciences
University of South Australia
City East Campus
Adelaide SA 5000
Country 9979 0
Australia
Phone 9979 0
+61 8 83022736
Fax 9979 0
+61 8 83021163
Email 9979 0
[email protected]
Contact person for scientific queries
Name 907 0
Associate Professor Robert Milne
Address 907 0
Centre for Pharmaceutical Research
School of Pharmacy and Medical Sciences
University of South Australia
City East Campus
Adelaide SA 5000
Country 907 0
Australia
Phone 907 0
+61 8 83022335
Fax 907 0
+61 8 83021163
Email 907 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.