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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryCmax (Maximum Plasma Concentration)Baseline to Day 7Blood samples will be collected for analysis of afamelanotide plasma concentrations and understand what the maximum concentration in plasma is.
PrimaryAUC(0-t) (Area Under the Curve From Administration to Last Observed Concentration at Time t)Baseline to Day 7Blood samples will be collected for analysis of afamelanotide plasma concentrations.
SecondaryAUC(0-∞) (Area Under the Curve Extrapolated to Infinite Time)Baseline to Day 7

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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