A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients with Erythropoietic Protoporphyria (EPP). - CUV052

Clinuvel Europe Limited0 个研究点目标入组 34 人开始时间: 2023年10月16日最近更新: 2024年7月22日

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•Fourteen adult EPP adult patients aged between 18 and 70 years (inclusive) and fourteen EPP adolescents aged between 12 and 17 (inclusive)., Agree not to use any medications, Able to understand and sign the written Informed Consent Form ((and parents or legal representative in case of adolescent patients), Able and willing to follow the Protocol requirements

•Any personal or direct family history of melanoma., Any factor that may interfere with the skin reflectance measurements., Current cigarette smokers., History of drug abuse, licit or illicit., Regularly drinks more than four standard drinks of alcohol per day., Participation in any clinical trial during the 60 days before the study screening period., Has received afamelanotide in the last 60 days., Has donated 400 mL or more of blood or had significant blood loss during the eight weeks preceding screening., 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 or other local anaesthetics if used., Any significant illness during the four weeks before the study screening period., Any evidence of hepatic or renal impairment., Any contraindication to blood sampling., Female who is pregnant or lactating., Females of child-bearing potential not using adequate contraceptive measures or a life-style excluding pregnancy, for up to three months after the implant administration., Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures.

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