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Trial · Interventional

CompletedPhase 1Registry data

Implant Pharmacokinetic and Pharmacodynamic Study

NCTNCT03634137 (opens ClinicalTrials.gov in a new tab)Other idCUV028
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Overview

Status
Completed
Phase
Phase 1
Enrollment
24 participants (actual)
Sponsor
Clinuvel Pharmaceuticals Limited · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Sept 2009
Primary completion
Feb 2010
Completion
Mar 2010
First posted
16 Aug 2018
Last update posted
16 Aug 2018
Conditions
Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200920102011
  1. Ph 1

    Implant Pharmacokinetic and Pharmacodynamic Study

    NCT03634137

    Sept 2009 to Mar 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Afamelanotide Group 1Drug
  • Afamelanotide Group 2Drug

Arms2

  • Experimental

    Afamelanotide Group 1

    A 16 mg bioresorbable afamelanotide implant (Group 1) from the previous manufacturing process.

  • Experimental

    Afamelanotide Group 2

    A 16 mg bioresorbable afamelanotide implant (Group 2) from the optimized final manufacturing process.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in skin melanin density

    Time frame · 120 days

    Registry description

    To confirm serial changes in skin melanin density by reflectance spectrophotometry following administration of the final formulation afamelanotide bioresorbable implants in healthy volunteers.

Secondary outcomes(2)

  1. Change in plasma concentrations of afamelanotide

    Time frame · 60 days

    Registry description

    To confirm the pharmacokinetics of afamelanotide by assessing afamelanotide plasma concentration following administration of the final formulation afamelanotide bioresorbable implants in healthy volunteers.

  2. Number of Adverse Events

    Time frame · 60 days

    Registry description

    To confirm the tolerance of afamelanotide by assessing adverse events following administration of the final formulation afamelanotide implants in healthy volunteers.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 45 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Healthy Caucasian adults aged between 18 and 45 years (inclusive). * Free of significant abnormal findings as determined during the screening procedure by surgical and medical history, physical examination, ECG, clinical laboratory testing and vital signs. * BMI between 18 and 30 kg/m2 (inclusive). * No history of drug abuse, licit or illicit (including alcohol). * Agree not to use any medications (prescribed medicines, over-the-counter medications, dietary supplements or nutraceuticals) without pre-approval by the Principal Investigator or nominee during the 7 days preceding the study, and during the course of the study (until Day 60) * Willing to take precautions to prevent pregnancy until completion of the study (Day 60). * Able to understand and sign the written Informed Consent Form. * Able and willing to follow the Protocol requirements, including refraining from the use of melanogenic (tanning) products and recreational sun or UV light exposure from the start of the study until Day 60 Exclusion Criteria: * Any significant history of allergy and/or sensitivity to any of the contents of study drug product. * Any significant history of allergy and/or sensitivity to lignocaine or other local anaesthetic. * Any evidence of organ dysfunction or any clinically significant deviation from normal in the physical or clinical determinations. * Personal history of melanoma, dysplastic nevus syndrome or family history of melanoma in a first degree relative. * Any evidence at the screening medical examination of hypertension or hypotension. Hypertension is defined as three separate readings that persistently read over 140/90 mmHg systolic/diastolic. Hypotension is defined as three separate readings that persistently read under 90/50 mmHg systolic/diastolic. * A pulse rate of less than 50 beats/minute. * Any significant illness during the 4 weeks before the study screening period. * Any contraindication to blood sampling. * Any factor that may interfere with the skin reflectance measurements (e.g. vitiligo, albinism, excessive number of moles, or excessively hairy skin). * Positive screening urine drugs of abuse test. * Participation in any clinical study during the 4 weeks before the study screening period. * Has donated 400 mL or more of blood or had significant blood loss during the 8 weeks preceding screening. * Has donated plasma within the 7 days preceding screening. * Have consumed alcohol during the 24 hours prior to Day 1

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