Effect of Food on the Oral Bioavailability of a Prolonged release Vamifeport in Healthy Volunteers

• Research type

  Research Study

• Full title

  A Phase 1, Randomized, Open-label Study to Characterize the Effect of Food on the Oral Bioavailability of a Prolonged Release Formulation of Vamifeport in Healthy Adult Subjects

• IRAS ID

  1011583

• Contact name

  Joanna Rutecka

• Contact email

  cta.gra@cslbehring.com

• Sponsor organisation

  CSL Behring LLC

• Clinicaltrials.gov Identifier

  NCT06996184

• Research summary

  This is a phase I, single-center, randomized, open-label, single-dose, 2-way, 2-period, crossover study to evaluate the effect of food on the pharmacokinetics (PK) of vamifeport prolonged-release (PR) formulation in healthy adult participants. Participants will be randomly allocated to one of two treatment sequences.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  25/EE/0024

• Date of REC Opinion

  9 Apr 2025

• REC opinion

  Further Information Favourable Opinion