Pharmacokinetics of Afamelanotide in EPP Patients
Phase 1
Completed
- Conditions
- Erythropoietic Protoporphyria
- Interventions
- Registration Number
- NCT06388642
- Lead Sponsor
- Clinuvel Europe Limited
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Afamelanotide 16 mg implant Afamelanotide 16mg implant -
- Primary Outcome Measures
Name Time Method Cmax (maximum Plasma Concentration) Baseline to Day 7 Blood samples will be collected for analysis of afamelanotide plasma concentrations and understand what the maximum concentration in plasma is.
AUC(0-t) (area under the curve from administration to last observed concentration at time t) Baseline to Day 7 Blood samples will be collected for analysis of afamelanotide plasma concentrations.
- Secondary Outcome Measures
Name Time Method AUC(0-∞) (area under the curve extrapolated to infinite time) Baseline to Day 7
Trial Locations
- Locations (1)
CLINUVEL Site
🇳🇱Rotterdam, Netherlands