Implant Pharmacokinetic and Pharmacodynamic Study

Summary

This is a single center, pharmacokinetic and pharmacodynamic study in healthy volunteers. Twenty four subjects will be enrolled in the study and will be assigned to receive either a 16 mg afamelanotide bioresorbable implant from the current manufacturing process or a 16 mg afamelanotide bioresorbable implant from the optimized manufacturing process. Implants will be administered subcutaneously. The following procedures will be conducted throughout the study: * Collection of blood samples for analysis of afamelanotide concentrations * Measurement of skin reflectance for estimation of melanin density, and luminance (L\*), blue/yellow colour hue (b\*) * Safety monitoring

Timeline

Start

2009-09

Primary completion

2010-02

Completion

2010-03

Drugs

Indications

No indication recorded.