BridgeMD
A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients with Erythropoietic Protoporphyria (EPP).
EU CTIS ID: 2023-507311-35-00
What this study is testing
To determine the pharmacokinetics of afamelanotide following administration of afamelanotide to adolescent and adult EPP patients. To determine the relative comparability of the PK profiles of afamelanotide in adolescent and adult EPP patients.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Fourteen adult EPP adult patients aged between 18 and 70 years (inclusive) and fourteen EPP adolescents aged between 12 and 17 (inclusive).
- Agree not to use any medications
- Able to understand and sign the written Informed Consent Form ((and parents or legal representative in case of adolescent patients)
- Able and willing to follow the Protocol requirements
You likely can't join if
- Any personal or direct family history of melanoma.
- Any factor that may interfere with the skin reflectance measurements.
- Current cigarette smokers.
- History of drug abuse, licit or illicit.
- Regularly drinks more than four standard drinks of alcohol per day.
- Participation in any clinical trial during the 60 days before the study screening period.
See the full eligibility criteria
- Fourteen adult EPP adult patients aged between 18 and 70 years (inclusive) and fourteen EPP adolescents aged between 12 and 17 (inclusive).
- Agree not to use any medications
- Able to understand and sign the written Informed Consent Form ((and parents or legal representative in case of adolescent patients)
- Able and willing to follow the Protocol requirements
- Any personal or direct family history of melanoma.
- Any factor that may interfere with the skin reflectance measurements.
- Current cigarette smokers.
- History of drug abuse, licit or illicit.
- Regularly drinks more than four standard drinks of alcohol per day.
- Participation in any clinical trial during the 60 days before the study screening period.
- Has received afamelanotide in the last 60 days.
- Has donated 400 mL or more of blood or had significant blood loss during the eight weeks preceding screening.
- 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 anaesthetics if used.
- Any significant illness during the four weeks before the study screening period.
- Any evidence of hepatic or renal impairment.
- Any contraindication to blood sampling.
- Female who is pregnant or lactating.
- Females of child-bearing potential not using adequate contraceptive measures or a life-style excluding pregnancy, for up to three months after the implant administration.
- Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.