None listed
Conditions
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.
Interventions
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.
Sponsors
Clinuvel Pharmaceuticals Limited
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
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.
Outcome results
None listed