Pharmacokinetics of Afamelanotide in EPP Patients

Erythropoietic Protoporphyria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06388642
• Other study ID #: CUV052
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 7, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2024
• Source: Clinuvel Pharmaceuticals Limited
• Contact: Head of Clinical Operations
• Phone: +441372860765
• Email: mail[@]clinuvel.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Erythropoietic Protoporphyria

Intervention

Drug:
• Afamelanotide 16mg implant
afamelanotide 16mg implant will be administered to each patient during the study.

Locations

Country	Name	City	State
Belgium	CLINUVEL Site	Leuven
Netherlands	CLINUVEL Site	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Clinuvel Europe Limited

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

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