NCT03634137

Implant Pharmacokinetic and Pharmacodynamic Study

A Phase Ib Study to Confirm the Pharmacokinetics and Melanogenic Potential of Controlled-Release Bioresorbable Implants of Afamelanotide in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Clinuvel Pharmaceuticals Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Detailed description

The objective of the proposed study is to confirm that the pharmacokinetic and pharmacodynamic properties of implants eluting 16 mg of afamelanotide produced by this final optimized manufacturing process are essentially the same as those of implants manufactured with the same formulation that have been used in earlier clinical studies The study will involve the use of an implant, which comes in the form of a small rod to be administered under the skin. 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Afamelanotide Group 1	One 16 mg bioresorbable afamelanotide implant (Group 1) from the previous manufacturing process.
DRUG	Afamelanotide Group 2	One 16 mg bioresorbable afamelanotide implant (Group 2) from the optimized final manufacturing process.

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-02-01
• Completion: 2010-03-01
• First posted: 2018-08-16
• Last updated: 2018-08-16

Locations

1 site across 1 country: United States