Pharmacokinetics of Afamelanotide in EPP Patients

NCT ID: NCT06388642

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-07
• Study Completion Date: 2025-01-20

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.

Conditions

Erythropoietic Protoporphyria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Afamelanotide 16 mg implant

Group Type: EXPERIMENTAL

Afamelanotide 16mg implant

Intervention Type: DRUG

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

Interventions

Afamelanotide 16mg implant

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinuvel Europe Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CLINUVEL Site

Leuven, , Belgium

CLINUVEL Site

Rotterdam, , Netherlands

Countries

Belgium; Netherlands

Other Identifiers

CUV052

Identifier Type: -

Identifier Source: org_study_id