Pharmacokinetics of Afamelanotide in EPP Patients

Clinuvel Europe Limited28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Erythropoietic Protoporphyria

Interventions

Afamelanotide 16mg implantDRUG

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

Eligibility

Sex: ALLMin age: 12 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

CLINUVEL Site

Leuven, Belgium

CLINUVEL Site

Rotterdam, Netherlands

Outcomes

Primary Outcomes

Cmax (maximum Plasma Concentration)

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

Time frame: Baseline to Day 7

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.

Time frame: Baseline to Day 7

Secondary Outcomes

AUC(0-∞) (area under the curve extrapolated to infinite time)

Time frame: Baseline to Day 7

Data from ClinicalTrials.gov

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