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Completed

NCT Number: NCT06996184

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

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigator Site 82600083

Leeds, West Yorkshire, LS11 9E, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vamifeport (PR formulation)

Drug

Vamifeport will be administered orally

Other names: CSL624

Primary outcomes

  1. 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

  2. AUC from time zero extrapolated to infinity (AUC0-inf) of vamifeport

    Time frame: 0-96 hours after dose

  3. Maximum observed plasma concentration (Cmax) of vamifeport

    Time frame: 0-96 hours after dose

Secondary outcomes

  1. 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)

  2. Percentage of participants with TEAEs overall, by severity, seriousness, and relationship to vamifeport

    Time frame: Up to Day 13 (+/- 2 days)

  3. 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)

  4. 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)

  5. Time of the maximum observed plasma concentration (Tmax) of vamifeport

    Time frame: 0-96 hours after dose

  6. Apparent terminal disposition phase plasma half life (t1/2) of vamifeport

    Time frame: 0-96 hours after dose

  7. Apparent terminal disposition rate constant (λz) of vamifeport

    Time frame: 0-96 hours after dose

  8. Apparent total clearance (CL/F) of vamifeport

    Time frame: 0-96 hours after dose

  9. Apparent volume of distribution (V/F) of vamifeport

    Time frame: 0-96 hours after dose

  10. Percentage of AUC due to extrapolation from the last quantifiable concentration to infinity (%AUCextrap) of vamifeport

    Time frame: 0-96 hours after dose

  11. Time of the last quantifiable concentration (Tlast) of vamifeport

    Time frame: 0-96 hours after dose

  12. The time taken for vamifeport to appear in the systemic circulation following administration (Tlag), when applicable

    Time frame: 0-96 hours after dose

  13. 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

  14. Plasma concentration of vamifeport

    Time frame: At 12 hours and 24 hours after dose

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 30, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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