Pharmacokinetics of Afamelanotide in EPP Patients

Clinuvel

Status and phase: Completed; Phase 2; Phase 1

Conditions: Erythropoietic Protoporphyria

Treatments: Drug: Afamelanotide 16mg implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT06388642

CUV052

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Afamelanotide 16 mg implant

Experimental group

Treatment:

Drug: Afamelanotide 16mg implant