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Completed
NCT06388642
Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients
Conditions: Erythropoietic Protoporphyria
Sex: All
Ages: 12 Years – 70 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 28
Sponsor: Clinuvel Europe Limited
Location: CLINUVEL Site Leuven
Summary
The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients.
Eligibility Criteria
Inclusion Criteria:
* EPP patients aged between 12 and 70 years
* BMI between 15 and 30 kg/m2
* \>50 kg
Exclusion Criteria:
* Any personal or direct family history of melanoma
* Any significant history of allergy and/or sensitivity to any of the contents of study drug product or 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
Source: ClinicalTrials.gov (NCT06388642). StuddyBuddy aggregates publicly available trial information.
