A Study to Determine the Pharmacokinetics and Melanogenic Potential of a Controlled-Release Formulation of Afamelanotide in Healthy Male Volunteers

Clinuvel Pharmaceuticals Limited0 个研究点目标入组 12 人开始时间: 2011年7月27日最近更新: 2020年1月13日

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•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

•* 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
•* 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.

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