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Completed

NCT Number: NCT06388642

Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients

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.

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Key information

Conditions

Erythropoietic Protoporphyria Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Liver Diseases Metabolic Diseases Nutritional and Metabolic Diseases Porphyrias Porphyrias, Hepatic Protoporphyria, Erythropoietic Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

CLINUVEL Site, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Afamelanotide 16mg implant

Drug

afamelanotide 16mg implant will be administered to each patient during the study.

Other names: SCENESSE®

Primary outcomes

  1. Cmax (Maximum Plasma Concentration)

    Time frame: Baseline to Day 7

    Blood samples will be collected for analysis of afamelanotide plasma concentrations and understand what the maximum concentration in plasma is.

  2. AUC(0-t) (Area Under the Curve From Administration to Last Observed Concentration at Time t)

    Time frame: Baseline to Day 7

    Blood samples will be collected for analysis of afamelanotide plasma concentrations.

Secondary outcomes

  1. AUC(0-∞) (Area Under the Curve Extrapolated to Infinite Time)

    Time frame: Baseline to Day 7

Sponsors and collaborators

Lead sponsor

Clinuvel Europe Limited

Industry

Registry information

Official study title

A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients With Erythropoietic Protoporphyria (EPP)

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 29, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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