Implant Pharmacokinetic and Pharmacodynamic Study

NCT03634137 | Completed Phase 1

• 1 other identifier: CUV028
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Afamelanotide; Nontherapeutic Human Experimentation in healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Change in skin melanin density

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

  120 days

Secondary Outcomes (2)

• Change in plasma concentrations of afamelanotide

  60 days

• Number of Adverse Events

  60 days

Study Arms (2)

Afamelanotide Group 1

EXPERIMENTAL

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

Drug: Afamelanotide Group 1

Afamelanotide Group 2

EXPERIMENTAL

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

Drug: Afamelanotide Group 2

Interventions

Afamelanotide Group 1 DRUG

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

Also known as: afamelanotide

Afamelanotide Group 1

Afamelanotide Group 2 DRUG

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

Also known as: afamelanotide

Afamelanotide Group 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinuvel Pharmaceuticals Limited: lead

Study Sites (1)

Prism Research Inc.

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Interventions

afamelanotide

Study Officials

• Mark A Matson, MD

  Prism Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants were assigned to receive either a 16 mg bioresorbable afamelanotide implant from the previous manufacturing process or a 16 mg bioresorbable afamelanotide implant from the optimized final manufacturing process.

Study Record Dates

• First Submitted: March 29, 2010
• First Posted: August 16, 2018
• Study Start: September 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

US (1)