Healthy Volunteers
Conditions
Brief 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.
Interventions
DRUGVamifeport (PR formulation)
Vamifeport will be administered orally
Sponsors
CSL Behring
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* •Aged greater than or equal to (\>=) 18 to less than or equal to (\<=) 60 years at the time of providing written informed consent. * •Healthy, as determined by the investigator based on review of defined assessments during Screening. * •Body weight between 50 and 100 kilogram (kg) (inclusive) and body mass index within the range 18.0 to 30.0 kg per square metre (kg/m2) (inclusive) at Screening and Day - 1.
Exclusion criteria
* •Any clinically relevant abnormal means of triplicate 12-lead ECG finding at Screening or Day - 1 (as deemed by the investigator). * •Serum ferritin of less than (\<) 30 nanograms per milliliter (ng/mL) or greater than (\>) 300 ng/mL for assigned male at birth (AMAB) participants or \< 16 ng/mL or \> 300 ng/mL for assigned female at birth (AFAB) participants at Screening or Day - 1. * •Hemoglobin \< 13 gram per deciliter (g/dL) (8.1 millimole per liter \[mmol/L\]) for AMAB participants or \< 12 g/dL (7.5 mmol/L) for AFAB participants at Screening or Day - 1. * •Blood draw or donation of blood (\>= 450 mL) within 3 months before Screening, plasma donation from 2 weeks before Screening, or platelet donation from 6 weeks before Screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of vamifeport | 0-96 hours after dose |
| AUC from time zero extrapolated to infinity (AUC0-inf) of vamifeport | 0-96 hours after dose |
| Maximum observed plasma concentration (Cmax) of vamifeport | 0-96 hours after dose |
Secondary
| Measure | Time frame |
|---|---|
| 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 | Up to Day 13 (+/- 2 days) |
| Time of the maximum observed plasma concentration (Tmax) of vamifeport | 0-96 hours after dose |
| Apparent terminal disposition phase plasma half life (t1/2) of vamifeport | 0-96 hours after dose |
| Apparent terminal disposition rate constant (λz) of vamifeport | 0-96 hours after dose |
| Apparent total clearance (CL/F) of vamifeport | 0-96 hours after dose |
| Number of participants with treatment emergent adverse events (TEAEs) overall, by severity, seriousness, and relationship to vamifeport | Up to Day 13 (+/- 2 days) |
| Percentage of AUC due to extrapolation from the last quantifiable concentration to infinity (%AUCextrap) of vamifeport | 0-96 hours after dose |
| Time of the last quantifiable concentration (Tlast) of vamifeport | 0-96 hours after dose |
| The time taken for vamifeport to appear in the systemic circulation following administration (Tlag), when applicable | 0-96 hours after dose |
| AUC from time zero to 12 hours (AUC0-12) and 24 hours (AUC0-24) of vamifeport | 0-12 hours post-dose and 0-24 hours after dose |
| Plasma concentration of vamifeport | At 12 hours and 24 hours after dose |
| Apparent volume of distribution (V/F) of vamifeport | 0-96 hours after dose |
| Percentage of participants with TEAEs overall, by severity, seriousness, and relationship to vamifeport | 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 | Up to Day 13 (+/- 2 days) |
Countries
United Kingdom
Outcome results
None listed