* Food Effect Bioavailability study comparing 2 vamifeport formulations

• Research type

  Research Study

• Full title

  A Randomised, Open-Label, Food Effect and Formulation Bioavailability Study of Two Vamifeport Oral Formulations in Healthy Male and Female Adults

• IRAS ID

  302107

• Contact name

  Hamzah Malik

• Contact email

  hamzah.malik@labcorp.com

• Sponsor organisation

  Vifor (International) Inc.

• Eudract number

  2021-003187-27

• Clinicaltrials.gov Identifier

  NCT05077436

• Duration of Study in the UK

  0 years, 2 months, 20 days

• Research summary

  Summary of Research
  Vifor Pharma is developing vamifeport as an oral FPN inhibitor and mimic of hepcidin, to provide a novel approach for the treatment of iron overload in thalassemia (a disease characterised by abnormal haemoglobin production) and other conditions that involve ineffective erythropoiesis (red blood cell formation), excessive iron absorption, excessive production of red cells, and/or regular RBC transfusions. Through its action on FPN, hepcidin controls major iron flows into the plasma. Like hepcidin, vamifeport induces FPN uptake by cells and its destruction within them, blocking iron export into the blood. FPN is mainly expressed on cells of the intestine, spleen, immune system, and liver cells. From the intestinal cells, FPN exports the dietary iron into the plasma; on spleen and liver macrophages and hepatocytes (liver cells), it exports iron recycled from the haemoglobin (Hb) of dying red blood cells (RBCs) and released from the liver stores, respectively.

  This is a phase 1, open-label, randomised, two-treatment under fast/fed condition, four-sequence, cross-over study in healthy adult male and female participants. Two different vamifeport oral formulations (vamifeport API-in capsules and vamifeport Blend-in capsules) will be administered in fed (high-calorie, high-fat meal) and fasted state to characterise the vamifeport food-drug interaction and to test the relative bioavailability (the proportion of drug entering the circulation) of the vamifeport Blend-in capsule formulation to the API in capsule formulation in healthy adult participants. Participants will be randomly allocated to one of four treatment sequences, including four treatment periods (TP) each, where different combinations of both formulations will be administered following fasted and fed state.

  The study consists of a screening period (Day -28 to Day -1), four TP of four days each including three days washout periods in between, and one safety follow-up period (10 +/- 2 days post dose).

  Summary of Results
  : Vamifeport is an experimental drug that inhibits iron transport into the blood stream. In this study the interaction with food of two oral vamifeport formulations were assessed in healthy volunteers. Safety and tolerability of vamifeport was also assessed and if the two formulations behaved in the body the same. A high-fat and high-caloric breakfast ingested together with vamifeport did lower vamifeport’s oral absorption. The two assessed formulation behaved the same in the body of healthy volunteers. As expected, vamifeport was well tolerated and safe in healthy volunteers

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  21/FT/0114

• Date of REC Opinion

  6 Sep 2021

• REC opinion

  Further Information Favourable Opinion