A Study to Evaluate the Pharmacokinetics of Afamelanotide in Patients With Erythropoietic Protoporphyria (EPP)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Clinuvel Europe Limited
- Enrollment
- 28
- Locations
- 2
- Primary Endpoint
- Cmax (maximum Plasma Concentration)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •EPP patients aged between 12 and 70 years
- •BMI between 15 and 30 kg/m2
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
Arms & Interventions
Afamelanotide 16 mg implant
Intervention: Afamelanotide 16mg implant (Drug)
Outcomes
Primary Outcomes
Cmax (maximum Plasma Concentration)
Time Frame: Baseline to Day 7
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
Blood samples will be collected for analysis of afamelanotide plasma concentrations.
Cmax (Maximum Plasma Concentration)
Time Frame: Baseline to Day 7
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
Blood samples will be collected for analysis of afamelanotide plasma concentrations.
Secondary Outcomes
- AUC(0-∞) (area under the curve extrapolated to infinite time)(Baseline to Day 7)
- AUC(0-∞) (Area Under the Curve Extrapolated to Infinite Time)(Baseline to Day 7)