Clinical trial NCT06996184: Effect of Food on the Oral Bioavailability of a Prolonged-release Formulation of Vamifeport in Healthy Adults
Official title: A Phase 1, Randomized, Open-label Study to Characterize the Effect of Food on the Oral Bioavailability of a Prolonged-release Formulation of Vamifeport in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2025-05-30
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of vamifeport
timeFrame: 0-96 hours after dose
measure: AUC from time zero extrapolated to infinity (AUC0-inf) of vamifeport
timeFrame: 0-96 hours after dose
measure: Maximum observed plasma concentration (Cmax) of vamifeport
timeFrame: 0-96 hours after dose
Secondary outcomes:
measure: Number of participants with treatment emergent adverse events (TEAEs) overall, by severity, seriousness, and relationship to vamifeport
timeFrame: Up to Day 13 (+/- 2 days)
measure: Percentage of participants with TEAEs overall, by severity, seriousness, and relationship to vamifeport
timeFrame: Up to Day 13 (+/- 2 days)
measure: 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
timeFrame: Up to Day 13 (+/- 2 days)
measure: 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
timeFrame: Up to Day 13 (+/- 2 days)
measure: Time of the maximum observed plasma concentration (Tmax) of vamifeport
timeFrame: 0-96 hours after dose
measure: Apparent terminal disposition phase plasma half life (t1/2) of vamifeport
timeFrame: 0-96 hours after dose
measure: Apparent terminal disposition rate constant (λz) of vamifeport
timeFrame: 0-96 hours after dose
measure: Apparent total clearance (CL/F) of vamifeport
timeFrame: 0-96 hours after dose
measure: Apparent volume of distribution (V/F) of vamifeport
timeFrame: 0-96 hours after dose
measure: Percentage of AUC due to extrapolation from the last quantifiable concentration to infinity (%AUCextrap) of vamifeport
timeFrame: 0-96 hours after dose
measure: Time of the last quantifiable concentration (Tlast) of vamifeport
timeFrame: 0-96 hours after dose
measure: The time taken for vamifeport to appear in the systemic circulation following administration (Tlag), when applicable
timeFrame: 0-96 hours after dose
measure: AUC from time zero to 12 hours (AUC0-12) and 24 hours (AUC0-24) of vamifeport
timeFrame: 0-12 hours post-dose and 0-24 hours after dose
measure: Plasma concentration of vamifeport
timeFrame: At 12 hours and 24 hours after dose
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Investigator Site 82600083
state: West Yorkshire
Study officials:
affiliation: CSL Behring
name: Study Director
role: STUDY_DIRECTOR
References: