Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Melanotan I.

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.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 28 actual participants took part.

It was open to people of any sex aged from 12 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: EPP patients aged between 12 and 70 years. BMI between 15 and 30 kg/m2.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: any personal or direct family history of melanoma; any evidence of hepatic or renal impairment.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Melanotan I study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-03-07 with completion listed for 2024-10-28.

It ran at 2 sites in Belgium (1) and Netherlands (1).

Its stated primary purpose is other.

What Was Measured

Primary outcome: Cmax (Maximum Plasma Concentration) (time frame: Baseline to Day 7). AUC(0-t) (Area Under the Curve From Administration to Last Observed Concentration at Time t) (time frame: Baseline to Day 7).

It also tracked 1 secondary outcome, for example AUC(0-∞) (Area Under the Curve Extrapolated to Infinite Time).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Melanotan I in 28 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Melanotan I compound page, all human trials.