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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
28
Vamifeport will be administered orally
Investigator Site 82600083
Leeds, West Yorkshire, United Kingdom
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of vamifeport
Time frame: 0-96 hours after dose
AUC from time zero extrapolated to infinity (AUC0-inf) of vamifeport
Time frame: 0-96 hours after dose
Maximum observed plasma concentration (Cmax) of vamifeport
Time frame: 0-96 hours after dose
Number of participants with treatment emergent adverse events (TEAEs) overall, by severity, seriousness, and relationship to vamifeport
Time frame: Up to Day 13 (+/- 2 days)
Percentage of participants with TEAEs overall, by severity, seriousness, and relationship to vamifeport
Time frame: Up to Day 13 (+/- 2 days)
Number of participants with clinically significant changes from baseline in clinical laboratory safety tests (biochemistry, hematology, and urinalysis), 12-lead electrocardiogram (ECG), and vital signs, reported as TEAEs
Time frame: Up to Day 13 (+/- 2 days)
Percentage of participants with clinically significant changes from baseline in clinical laboratory safety tests (biochemistry, hematology, and urinalysis), 12-lead ECG, and vital signs, reported as TEAEs
Time frame: Up to Day 13 (+/- 2 days)
Time of the maximum observed plasma concentration (Tmax) of vamifeport
Time frame: 0-96 hours after dose
Apparent terminal disposition phase plasma half life (t1/2) of vamifeport
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Time frame: 0-96 hours after dose
Apparent terminal disposition rate constant (λz) of vamifeport
Time frame: 0-96 hours after dose
Apparent total clearance (CL/F) of vamifeport
Time frame: 0-96 hours after dose
Apparent volume of distribution (V/F) of vamifeport
Time frame: 0-96 hours after dose
Percentage of AUC due to extrapolation from the last quantifiable concentration to infinity (%AUCextrap) of vamifeport
Time frame: 0-96 hours after dose
Time of the last quantifiable concentration (Tlast) of vamifeport
Time frame: 0-96 hours after dose
The time taken for vamifeport to appear in the systemic circulation following administration (Tlag), when applicable
Time frame: 0-96 hours after dose
AUC from time zero to 12 hours (AUC0-12) and 24 hours (AUC0-24) of vamifeport
Time frame: 0-12 hours post-dose and 0-24 hours after dose
Plasma concentration of vamifeport
Time frame: At 12 hours and 24 hours after dose