Effect of Food on the Oral Bioavailability of a Prolonged-release Formulation of Vamifeport in Healthy Adults

Phase 1

Active, not recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: Vamifeport (PR formulation)

• Registration Number: NCT06996184
• Lead Sponsor: CSL Behring

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-05-21
• Study Start: 2025-05-27
• Study First Posted: 2025-05-30
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-06-27
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1: Vamifeport Fasted then Fed	Vamifeport (PR formulation)	In sequence 1, eligible participants assigned to sequence 1 will receive a single vamifeport dose on an empty stomach on Day 1 (fasted condition), undergo a washout period, and then receive a single vamifeport dose after a standardized high-fat meal (fed condition) on Day 6.
Sequence 2: Vamifeport Fed then Fasted	Vamifeport (PR formulation)	In sequence 2, eligible participants assigned to sequence 2 will receive a single vamifeport dose after a standardized high-fat meal on Day 1 (fed condition), undergo a washout period, and then receive a single vamifeport dose on an empty stomach (fasted condition) on Day 6.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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)
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
Apparent volume of distribution (V/F) of vamifeport	0-96 hours after dose
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

Trial Locations

Locations (1)

Investigator Site 82600083; 🇬🇧 Leeds, West Yorkshire, United Kingdom