Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients

NCTNCT06388642Other idCUV052

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 1/2
Enrollment: 28 participants (actual)
Sponsor: Clinuvel Europe Limited · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 2 countries
Belgium, Netherlands
Start: 7 Mar 2024
Primary completion: 28 Oct 2024
Completion: 20 Jan 2025
First posted: 29 Apr 2024
Last update posted: 27 Jul 2026
Conditions: Erythropoietic Protoporphyria

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202420252026

Ph 1/2
Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients
NCT06388642
7 Mar 2024 to 20 Jan 2025

Registry summary

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

The purpose of this study is to evaluate the concentration of afamelanotide in serum after the administration of afamelanotide in adolescent and adult EPP patients.

Interventions

Afamelanotide 16mg implantDrug

Arms1

Experimental
Afamelanotide 16 mg implant

Primary outcomes2

Outcomes the sponsor listed as primary.

Cmax (Maximum Plasma Concentration)
Time frame · Baseline to Day 7
Registry description
Blood samples will be collected for analysis of afamelanotide plasma concentrations and understand what the maximum concentration in plasma is.
AUC(0-t) (Area Under the Curve From Administration to Last Observed Concentration at Time t)
Time frame · Baseline to Day 7
Registry description
Blood samples will be collected for analysis of afamelanotide plasma concentrations.

Secondary outcomes(1)

AUC(0-∞) (Area Under the Curve Extrapolated to Infinite Time)
Time frame · Baseline to Day 7

Posted results

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

Primary outcome results

Primary outcomeGeometric mean· Baseline to Day 7

Cmax (Maximum Plasma Concentration)

Group	Value (ng/mL)
Afamelanotide 16 mg Implant	2.361

Primary outcomeGeometric mean· Baseline to Day 7

AUC(0-t) (Area Under the Curve From Administration to Last Observed Concentration at Time t)

Group	Value (h*ng/mL)
Afamelanotide 16 mg Implant	95.415

Secondary and other outcome results(1)

Secondary outcomeGeometric mean· Baseline to Day 7

AUC(0-∞) (Area Under the Curve Extrapolated to Infinite Time)

Group	Value (h*ng/mL)
Afamelanotide 16 mg Implant	114.406

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Afamelanotide 16 mg ImplantAfamelanotide 16mg implant: afamelanotide 16mg implant will be administered to each patient during the study.	0 / 28	0 / 28	23 / 28

Each cell reads participants affected / participants at risk, as the registry posted them.

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 12 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * EPP patients aged between 12 and 70 years * BMI between 15 and 30 kg/m2 * \>50 kg Exclusion Criteria: * Any personal or direct family history of melanoma * Any significant history of allergy and/or sensitivity to any of the contents of study drug product or 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

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