HealthyPhase 1NCT03634137
Implant Pharmacokinetic and Pharmacodynamic Study
A Phase 1 study testing Afamelanotide Group 1 and Afamelanotide Group 2 in people with Healthy, run by Clinuvel Pharmaceuticals Limited at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Afamelanotide Group 1 and Afamelanotide Group 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib Study to Confirm the Pharmacokinetics and Melanogenic Potential of Controlled-Release Bioresorbable Implants of Afamelanotide in Healthy Volunteers
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
Read the 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
- Being tested
- Afamelanotide Group 1, Afamelanotide Group 2
- Keywords
- Afamelanotide, Nontherapeutic Human Experimentation in healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afamelanotide Group 1Drug
Also called afamelanotide
One 16 mg bioresorbable afamelanotide implant (Group 1) from the previous manufacturing process.
Afamelanotide Group 2Drug
Also called afamelanotide
One 16 mg bioresorbable afamelanotide implant (Group 2) from the optimized final manufacturing process.
| Study group | Role | What they receive |
|---|---|---|
| Afamelanotide Group 1 | Experimental | A 16 mg bioresorbable afamelanotide implant (Group 1) from the previous manufacturing process. Receives: Drug: Afamelanotide Group 1 |
| Afamelanotide Group 2 | Experimental | A 16 mg bioresorbable afamelanotide implant (Group 2) from the optimized final manufacturing process. Receives: Drug: Afamelanotide Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 days
Secondary outcomes (2)
Change in plasma concentrations of afamelanotide
To confirm the pharmacokinetics of afamelanotide by assessing afamelanotide plasma concentration following administration of the final formulation afamelanotide bioresorbable implants in healthy volunteers.
Measured: 60 days
Number of Adverse Events
To confirm the tolerance of afamelanotide by assessing adverse events following administration of the final formulation afamelanotide implants in healthy volunteers.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study startSep 2009
- Primary completionFeb 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinuvel Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark A Matson, MD, Principal investigator, Prism Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634137
- Sponsor's protocol ID
- CUV028
- Status last verified
- Aug 2018
- First submitted
- 29 Mar 2010
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study to Confirm the Pharmacokinetics and Melanogenic Potential of Controlled-Release Bioresorbable Implants of Afamelanotide in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03634137
- Acronym / sponsor ID
- CUV028
- Conditions
- Healthy
- Keywords
- Afamelanotide, Nontherapeutic Human Experimentation in healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Clinuvel Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Afamelanotide Group 1 | Experimental | Drug: Afamelanotide Group 1A 16 mg bioresorbable afamelanotide implant (Group 1) from the previous manufacturing process. |
| Afamelanotide Group 2 | Experimental | Drug: Afamelanotide Group 2A 16 mg bioresorbable afamelanotide implant (Group 2) from the optimized final manufacturing process. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afamelanotide Group 1Also: afamelanotideOne 16 mg bioresorbable afamelanotide implant (Group 1) from the previous manufacturing process. | Drug | Afamelanotide Group 1 |
| Afamelanotide Group 2Also: afamelanotideOne 16 mg bioresorbable afamelanotide implant (Group 2) from the optimized final manufacturing process. | Drug | Afamelanotide Group 2 |
Primary outcome
Change in skin melanin density
Time frame: 120 days
To confirm serial changes in skin melanin density by reflectance spectrophotometry following administration of the final formulation afamelanotide bioresorbable implants in healthy volunteers.
2 secondary outcomes
Change in plasma concentrations of afamelanotide
Time frame: 60 days
Number of Adverse Events
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark A Matson, MD principal investigator
Prism Research Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Afamelanotide Group 1 and Afamelanotide Group 2 in people with Healthy, run by Clinuvel Pharmaceuticals Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skin melanin density (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.