Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000784910
Ethics application status
Approved
Date submitted
26/07/2011
Date registered
27/07/2011
Date last updated
25/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
CUV038: Measurement of drug blood levels over time in healthy male volunteers
Scientific title
A Study to Determine the Pharmacokinetics and Melanogenic Potential of a Controlled-Release Formulation of Afamelanotide in Healthy Male Volunteers
Secondary ID [1] 262705 0
CUV038
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The drug is intended to treat patients with light exposure disorders (for example UV light). 270410 0
Condition category
Condition code
Other 270554 270554 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Afamelanotide is a peptide molecule. The drug is a 16mg controlled-release, bioresorbable subcutaneous implant. This study seeks to determine the drug release profile over a 14 day period.
Intervention code [1] 267049 0
Treatment: Drugs
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269294 0
Afamelanotide plasma concentration-time profile.
Timepoint [1] 269294 0
Collection of blood samples for analysis of afamelanotide concentrations, at the
following time points; Day 0 (prior to implant administration; T=0 hours), Day 1 (2
hours, 4 hours, 8 hours, 12 hours, 24 hours and 36 hours after implant administration),
Day 2 (48 hours), Day 3 (72 hours), Day 4 (96 hours), Day 7 (168 hours), Day 10 (240
hours) and Day 14 (336 hours).
Secondary outcome [1] 279321 0
To confirm the safety and tolerability of afamelanotide in healthy male volunteers.
Timepoint [1] 279321 0
Measurement of melanin density on Day 0, 7, 10, 14, 21, 28, 60 and 90 days and safety monitoring up to 90 days inclusive.

Eligibility
Key inclusion criteria
Healthy adult males with Fitzpatrick skin types I, II or III aged between 18 and 45 years
(inclusive).
* Free of significant abnormal findings as determined during the screening procedure by surgical and medical history, physical examination, ECG, clinical laboratory testing and vital signs.
* BMI between 18 and 30 kg/m2.
* No history of drug abuse, licit or illicit (including alcohol).
* Agree not to use any medications (prescribed, over-the-counter or complementary medications) without pre-approval by the Principal Investigator during the 7 days preceding the study, and during the course of the study (until Day 90).
* Willing to take precautions to prevent pregnancy with their partner until completion of the study (Day 90) and 30 days thereafter.
* Able to understand and sign the written Informed Consent Form.
* Able and willing to follow the Protocol requirements, including refraining from the use of tanning products and excessive UV light exposure from the start of the study until Day 90
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any personal history of melanoma or dysplastic nevus syndrome.
* Any significant history of allergy and/or sensitivity to any of the contents of study drug
product.
* Any significant history of allergy and/or sensitivity to lignocaine.
* Any significant illness during the 4 weeks before the study screening period.
* Any contraindication to blood sampling.
* Any factor that may interfere with the skin reflectance measurements (e.g. excessive moles, freckles or excessively hairy skin).
* Regularly drinks more than 4 standard drinks of alcohol per day (1 standard drink = 300 mL
beer, 1 glass wine, 1 measure spirit).
* Participation in any clinical study during the 6 weeks before the study screening period.
* Has donated 400 mL or more of blood or had significant blood loss during the 8 weeks
preceding screening.
* Has donated plasma within the 7 days preceding screening.
* Solarium use in the three months prior to study involvement and throughout the duration of the study.

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)
Consenting and eligible subjects are implanted with active investigational medicinal product and all other study procedures are then conducted.
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
Single group
Other design features
Phase
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/07/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267521 0
Commercial sector/Industry
Name [1] 267521 0
Clinuvel Pharmaceuticals Limited
Country [1] 267521 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Clinuvel Pharmaceuticals Limited
Address
Level 14, 190 Queen St,
Melbourne, Victoria 3000
Australia
Country
Australia
Secondary sponsor category [1] 266563 0
None
Name [1] 266563 0
Address [1] 266563 0
Country [1] 266563 0
Other collaborator category [1] 252132 0
Commercial sector/Industry
Name [1] 252132 0
CPR Pharma Services Pty Ltd
Address [1] 252132 0
Suite C
32 West Thebarton Rd
THEBARTON SA 5031
Country [1] 252132 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269487 0
University SA Human Research Ethics Committee
Ethics committee address [1] 269487 0
Research and Innovation Services
Mawson Lakes Campus
University of South Australia
GPO Box 2471
Adelaide
South Australia 5001
http://www.unisa.edu.au/res/ethics/default.asp
Ethics committee country [1] 269487 0
Date submitted for ethics approval [1] 269487 0
15/06/2011
Approval date [1] 269487 0
04/07/2011
Ethics approval number [1] 269487 0

Summary
Brief summary
The purpose of this study is to measure drug blood levels in health male volunteers over a 14 day period. in addition, it is intended to assess the safety and effect of the drug in study subjects over a 90 day period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32926 0
Address 32926 0
Country 32926 0
Phone 32926 0
Fax 32926 0
Email 32926 0
Contact person for public queries
Name 16173 0
Lee Thomas
Address 16173 0
Office Manager
Clinuvel Pharmaceuticals Ltd
Level 14 / 190 Queen Street
Melbourne Victoria 3000 Australia
Country 16173 0
Australia
Phone 16173 0
+61 3 9660 4900
Fax 16173 0
+61 3 9660 4999
Email 16173 0
[email protected]
Contact person for scientific queries
Name 7101 0
Dr Sumith Nawaratne
Address 7101 0
Director, Clinical Research
Clinuvel Pharmaceuticals Ltd
Level 14, 190 Queen St,
Melbourne Victoria 3000 Australia
Country 7101 0
Australia
Phone 7101 0
+61 3 9660 4900
Fax 7101 0
Email 7101 0
[email protected]

No information has been provided regarding IPD availability


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.