PK and PD of 2 Prolonged release Formulations of Vamifeport in Healthy Adults
Research type
Research Study
Full title
A Phase 1, Randomized, Open-label Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Vamifeport after Multiple Oral Administration of One Immediate-release Formulation and after Single and Multiple Oral Administration of Two Prolonged-release Formulations in Healthy Adult Subjects
IRAS ID
1010578
Contact name
Joanna Rutecka
Contact email
Sponsor organisation
CSL Behring LLC
Clinicaltrials.gov Identifier
Research summary
Vamifeport is an investigational new drug being developed to treat certain blood disorders by changing the way the body handles iron. It is currently given as immediate-release (IR) capsules which work by immediately releasing the drug into the gut prior to it being absorbed into the bloodstream. This trial will study two new kinds of vamifeport capsules, called prolonged-release capsules 1 and 2 (PR1 and PR2), both of which release the drug more slowly into the gut prior to it being absorbed into the bloodstream. The trial will look at and compare how the different types of capsules affect how well vamifeport works, how the body handles the drug, and levels of drug and drug breakdown product in the body. It will also look at how safe vamifeport is when given in each of these different forms and any effect the drug might have on the heartbeat and kidneys.\nThe study aims to enroll 22 healthy volunteers who will be assessed for eligibility within 28 days prior to checking in to the research unit on Day -1. Starting from Day 1 volunteers will take four different treatments, one during each of four different treatment periods 1-4:\n\n1: vamifeport IR, 120mg three times a day, for 4 doses total\n2: vamifeport PR1 or PR2, 180mg twice a day, for 9 doses total\n3: vamifeport PR1 or PR2, 360mg as a single dose on Day 13\n4: vamifeport PR1 or PR2, 360mg as a single dose on Day 16\nThe type and order of treatment will be randomly assigned and will be known to the volunteer and study-team. The four treatment periods will be spread over 18 days of residency during which volunteers will be closely observed. An optional homestay is permitted between treatment periods 2 and 3. Safety follow-up will take place 5 days ±2 days after discharge. Total participation will last approximately 51 days.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
24/EE/0166
Date of REC Opinion
24 Oct 2024
REC opinion
Further Information Favourable Opinion