Erythropoietic Protoporphyria Clinical Trial
Official title:
A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients With Erythropoietic Protoporphyria (EPP)
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.
Status | Recruiting |
Enrollment | 28 |
Est. completion date | October 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | CLINUVEL Site | Leuven | |
Netherlands | CLINUVEL Site | Rotterdam |
Lead Sponsor | Collaborator |
---|---|
Clinuvel Europe Limited |
Belgium, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cmax (maximum Plasma Concentration) | Blood samples will be collected for analysis of afamelanotide plasma concentrations and understand what the maximum concentration in plasma is. | Baseline to Day 7 | |
Primary | AUC(0-t) (area under the curve from administration to last observed concentration at time t) | Blood samples will be collected for analysis of afamelanotide plasma concentrations. | Baseline to Day 7 | |
Secondary | AUC(0-8) (area under the curve extrapolated to infinite time) | Baseline to Day 7 |
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