Trial · NCT06388642
Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients
NCT06388642, Phase 1, Phase 2, Completed, Clinuvel Europe Limited
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients. Trials, record NCT06388642. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06388642
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetics of Afamelanotide in Erythropoietic Protoporphyria Patients
- NCT number
- NCT06388642
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Clinuvel Europe Limited
- Conditions
- Erythropoietic Protoporphyria
- Interventions
- Afamelanotide 16mg implant
- First posted
- 2024-04-29
- Last updated
- 2026-07-27
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cmax (Maximum Plasma Concentration) | Baseline to Day 7 | Blood samples will be collected for analysis of afamelanotide plasma concentrations and understand what the maximum concentration in plasma is. |
| Primary | AUC(0-t) (Area Under the Curve From Administration to Last Observed Concentration at Time t) | Baseline to Day 7 | Blood samples will be collected for analysis of afamelanotide plasma concentrations. |
| Secondary | AUC(0-∞) (Area Under the Curve Extrapolated to Infinite Time) | Baseline to Day 7 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06388642
GET https://conductscience.org/api/trials/v1/NCT06388642/registered