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Implant Pharmacokinetic and Pharmacodynamic Study

NCT03634137 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-08-16

No results posted yet for this 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

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Clinuvel Pharmaceuticals Limited

    lead INDUSTRY

Principal Investigators

  • Mark A Matson, MD · Prism Research Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-02-28
Completion
2010-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03634137 on ClinicalTrials.gov