Phase 2
Completed N=28
Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients
Source: ClinicalTrials.gov NCT06388642 ↗Enrolled (actual)
28
Serious AEs
—
Results posted
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax (maximum Plasma Concentration) |
— | — |
| PRIMARY AUC(0-t) (area under the curve from administration to last observed concentration at time t) |
— | — |
| SECONDARY AUC(0-∞) (area under the curve extrapolated to infinite time) |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT06388642). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.