Two different vamifeport oral formulations will be administered in fed and fasted state to assess the vamifeport food-drug interaction and to assess the relative bioavailability (the proportion of drug entering the circulation) of 2 different vamifeport oral formulations in healthy adult participants. Participants will be randomly allocated to one of four treatment sequences, with four dosing periods each, where different combinations of both formulations will be administered following fasted and fed state. The total study duration for each participant is up to 7 weeks and 4 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
28
Vamifeport Formulation 1 is available as 60 mg oral capsules
Vamifeport Formulation 2 is available as 60 mg oral capsules
Labcorp Clinical Research Unit Ltd.
Leeds, United Kingdom
Area under the plasma concentration versus time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-last) of vamifeport
Time frame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Area under the plasma concentration versus time curve from time 0 extrapolated to infinite time (AUC0-infinity) of vamifeport
Time frame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Maximum observed concentration (Cmax) of vamifeport
Time frame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Time of maximum vamifeport plasma concentration (Tmax)
Time frame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Apparent terminal disposition phase half-life (tl/2)
Time frame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Apparent terminal disposition phase rate constant
Time frame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Apparent total clearance
Time frame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Apparent volume of distribution during the terminal disposition phase
Time frame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
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