Implant Pharmacokinetic and Pharmacodynamic Study

What Was Tested

The trial (phase 1) is built around Melanotan I.

Implants will be administered subcutaneously.

It had two arms (groups): Afamelanotide Group 1 (experimental) and Afamelanotide Group 2 (experimental).

The registry classes the interventions as drug.

More on the Plan

For this study, afamelanotide has been formulated as a controlled release depot injection (implant).

This means that the afamelanotide will be released slowly into the body over a few days.

Once inserted, the implant will remain in the body after afamelanotide has been released and will slowly dissolve.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy Caucasian adults aged between 18 and 45 years (inclusive). BMI between 18 and 30 kg/m2 (inclusive). No history of drug abuse, licit or illicit (including alcohol). Able to understand and sign the written Informed Consent Form.

The full record lists 8 inclusion and 14 exclusion criteria; among the exclusions: personal history of melanoma, dysplastic nevus syndrome or family history of melanoma in a first degree relative; A pulse rate of less than 50 beats/minute; any contraindication to blood sampling.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Melanotan I study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Melanotan I group and the comparison group ran side by side rather than switching.

Everyone knew when Melanotan I was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2009-09 with completion listed for 2010-02.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Change in skin melanin density (time frame: 120 days).

It also tracked 2 secondary outcomes, for example Change in plasma concentrations of afamelanotide and Number of Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Melanotan I in 24 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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