CompletedPhase 1/2

Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients

Belgium, Netherlands28 participantsStarted 2024-03-07

Plain-language 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.

Who can participate

Age range12 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Cmax (maximum Plasma Concentration)

Timeframe: Baseline to Day 7

AUC(0-t) (area under the curve from administration to last observed concentration at time t)

Timeframe: Baseline to Day 7

Trial details

NCT IDNCT06388642

SponsorClinuvel Europe Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-10-28

Results submitted2026-03-24

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