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Completed

NCT Number: NCT06726863

Pharmacokinetics and Pharmacodynamics of Two Prolonged-release Formulations of Vamifeport in Healthy Adults

This is a phase 1, single-center, randomized, open-label study to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of vamifeport after multiple oral administrations of one immediate-release (IR) formulation and after single and multiple oral administrations of two prolonged-release (PR) formulation in healthy adult participants.

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Key information

Conditions

Healthy Volunteers Iron Metabolism Disorders Iron Overload Metabolic Diseases Nutritional and Metabolic Diseases

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, 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 when providing written informed consent.
  • Healthy, as determined by the investigator based on review of defined assessments during Screening.
  • Body weight between 50 and 100 kilograms (kg) (inclusive) and body mass index within the range 18.0 to 32.0 kg per meter squared (kg/m2) (inclusive) at Screening and Day -1.

Exclusion criteria

  • Any clinically relevant abnormal 12-lead ECG finding at Screening or Day -1 (as deemed by the investigator).
  • Serum ferritin of < 30 nanograms per milliliter (ng/mL) or > 300 ng/mL for assigned male at birth (AMAB) subjects or <16 ng/mL or > 300 ng/mL for assigned female at birth (AFAB) subjects at Screening or Day -1.
  • Hemoglobin < 13 grams per deciliter (g/dL) (8.1 millimoles per liter [mmol/L]) for AMAB subjects or 12 g/dL (7.5 mmol/L) for AFAB subjects at Screening or Day -1.
  • Blood draw or donation of blood (>= 450 mL) within 3 months before Screening, plasma from 2 weeks before Screening, or platelets from 6 weeks before Screening.

Treatment and study plan

Vamifeport IRF

Drug

Vamifeport IRF will be administered orally as per the dosing levels and formulations for respective treatment periods.

Other names: CSL624

Vamifeport PR1

Drug

Vamifeport PR1 will be administered orally as per the dosing levels and formulations for respective treatment periods.

Other names: CSL624

Vamifeport PR2

Drug

Vamifeport PR2 will be administered orally as per the dosing levels and formulations for respective treatment periods.

Other names: CSL624

Primary outcomes

  1. Plasma concentration-time course profiles of vamifeport

    Time frame: Treatment Period (TP) 2: Before and after dosing on Day 4 (up to 12 hours), Day 8 (up to 48 hours), Before dosing on Day 5, 6, 7 TP 3: Before and after dosing on Day 13 (up to 48 hours) TP 4: Before and after dosing on Day 16 (up to 48 hours)

  2. Maximum plasma concentration (Cmax) of first and last dose of vamifeport PR1 and PR2 in Treatment Period 2

    Time frame: TP2: Before, and up to 48 hours after, both the first and the last dose

  3. Time to reach Cmax (Tmax) of first and last dose vamifeport PR1 and PR2 in Treatment Period 2

    Time frame: TP 2: Before, and up to 48 hours after, both the first and the last dose

  4. Area under the plasma concentration curve from time zero to 12 hours (AUC0-12) of first and last dose of vamifeport PR1 and PR2 in Treatment Period 2

    Time frame: TP 2: Before, and up to 48 hours after, both the first and the last dose

  5. Trough concentration (Ctrough) of first dose of vamifeport PR1 and PR2 in Treatment Period 2

    Time frame: Before and up to 24 hours after the first dose in TP2

  6. AUC from time zero to infinity (AUC0-inf) of last dose of vamifeport PR1 and PR2 in Treatment Period 2

    Time frame: TP 2: Before, and up to 48 hours after last dose

  7. AUC from time zero to time tlast (AUC0-last) of last dose of vamifeport PR1 and PR2 in Treatment Period 2

    Time frame: TP 2: Before, and up to 48 hours after last dose

  8. AUC from time zero to 8 hours (AUC0-8) and 24 hours (AUC0-24) of last dose of vamifeport PR1 and PR2 in Treatment Period 2

    Time frame: TP 2: Before, and up to 8 and 24 hours after last dose

  9. Plasma concentration at 12 hours (Conc [t=12]) of last dose of vamifeport PR1 and PR2 in Treatment Period 2

    Time frame: TP 2: Before and up to 12 hours after last dose

  10. Apparent clearance (CL/F) of last dose of vamifeport PR1 and PR2 in Treatment Period 2

    Time frame: TP 2: Before, and up to 48 hours after last dose

  11. Apparent volume of distribution at steady state (Vss/F) of last dose of vamifeport PR1 and PR2 in Treatment Period 2

    Time frame: TP 2: Before, and up to 48 hours after last dose

  12. Accumulation ratio (Rac) of Cmax between first and last dose of vamifeport PR1 and PR2 in Treatment Period 2

    Time frame: TP 2: Before, and up to 48 hours after first and last dose

  13. Rac(Ctrough/Conc[t=12]) between first and last dose of vamifeport PR1 and PR2 in Treatment Period 2

    Time frame: TP 2: Before, and up to 12 hours after first and last dose

  14. Rac (AUC0-12) between first and last dose of vamifeport PR1 and PR2 in Treatment Period 2

    Time frame: TP 2: Before, and up to 12 hours after first and last dose

  15. Half-life (t1/2) after last dose of vamifeport PR1 and PR2 in Treatment Period 2

    Time frame: TP 2: Before, and up to 48 hours after last dose

  16. Cmax of vamifeport PR1 and PR2 in Treatment Period 3 and 4

    Time frame: Before and up to 48 hours after dosing, in TP3 and TP4

  17. Tmax of vamifeport PR1 and PR2 in Treatment Period 3 and 4

    Time frame: Before and up to 48 hours after dosing, in TP3 and TP4

  18. AUC0-inf of vamifeport PR1 and PR2 in Treatment Period 3 and 4

    Time frame: Before and up to 48 hours after dosing, in TP3 and TP4

  19. AUC0-last of vamifeport PR1 and PR2 in Treatment Period 3 and 4

    Time frame: Before and up to 48 hours after dosing, in TP3 and TP4

  20. AUC0-8, AUC0-12 and AUC0-24 of vamifeport PR1 and PR2 in Treatment Period 3 and 4

    Time frame: Before and up to 8, 12 and 24 hours after dosing, in TP3 and TP4

  21. Plasma Concentration at 8 hours (Conc [t=8]), 12 hours (Conc [t=12]) and 24 hours (Conc [t=24]) of vamifeport PR1 and PR2 in Treatment Period 3 and 4

    Time frame: Before and up to 8, 12 and 24 hours after dosing, in TP3 and TP4

  22. CL/F of vamifeport PR1 and PR2 in Treatment Period 3 and 4

    Time frame: Before and up to 48 hours after dosing, in TP3 and TP4

  23. t1/2 of vamifeport PR1 and PR2 in Treatment Period 3 and 4

    Time frame: Before and up to 48 hours after dosing, in TP3 and TP4

  24. Apparent volume of distribution (Vz/F) of vamifeport PR1 and PR2 in Treatment Period 3 and 4

    Time frame: Before and up to 48 hours after dosing, in TP3 and TP4

Secondary outcomes

  1. Number of participants with treatment-emergent (TE): adverse event (AE), AE by severity, AE related to vamifeport, and serious AE

    Time frame: Up to 25 days after treatment

  2. Percentage of participants with TEAE, AE by severity, AE related to vamifeport, and serious AE

    Time frame: Up to 25 days after treatment

  3. Number of participants with clinically significant change from Baseline in clinical laboratory safety tests, 12 lead Electrocardiogram (ECG), and vital signs

    Time frame: At baseline and up to 25 days after treatment

    The clinical laboratory safety tests include biochemistry, hematology, urinalysis.

  4. AUC0-24 of vamifeport PR1 and PR2 in Treatment Period 3 and 4

    Time frame: Before and up to 24 hours after dosing, in TP3 and TP4

    Comparison of AUC0-24 between PR1 and PR2

  5. AUC0-12 of vamifeport PR1 and PR2 in Treatment Period 3 and 4

    Time frame: Before and up to 12 hours after dosing, in TP3 and TP4

    Comparison of AUC0-12 between PR1 and PR2

  6. AUC0-inf of vamifeport PR1 and PR2 in Treatment Period 3 and 4

    Time frame: Before and up to 48 hours after dosing, in TP3 and TP4

    Comparison of AUC0-inf between PR1 and PR2

  7. Conc (t=12) of vamifeport PR1 and PR2 in Treatment Period 3 and 4

    Time frame: Before and up to 12 hours after dosing, in TP3 and TP4

    Comparison of conc(t=12) between PR1 and PR2

  8. Conc (t=24) of vamifeport PR1 and PR2 in Treatment Period 3 and 4

    Time frame: Before and up to 24 hours after dosing, in TP3 and TP4

    Comparison of conc(t=24) between PR1 and PR2

  9. Cmax of vamifeport PR1 and PR2 in Treatment Period 3 and 4

    Time frame: Before and up to 48 hours after dosing, in TP3 and TP4

    Comparison of cmax between PR1 and PR2

  10. Tmax of vamifeport PR1 and PR2 in Treatment Period 3 and 4

    Time frame: Before and up to 48 hours after dosing, in TP3 and TP4

    Comparison of tmax between PR1 and PR2

  11. Absolute values of serum iron

    Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4

  12. Absolute values of transferrin saturation (TSAT)

    Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4

  13. Change from baseline of serum iron

    Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4

  14. Change from baseline of TSAT

    Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4

  15. Maximum percentage change from baseline (Emax) of serum iron

    Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4

  16. Emax of TSAT

    Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4

  17. Time to Emax (TEmax) of serum iron

    Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4

  18. TEmax of TSAT

    Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4

  19. Time below baseline of serum iron

    Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4

  20. Time below baseline of TSAT

    Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4

  21. AUC below baseline of serum iron

    Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4

  22. AUC below baseline of TSAT

    Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

A Phase 1, Randomized, Open-label Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Vamifeport After Multiple Oral Administration of One Immediate-release Formulation and After Single and Multiple Oral Administration of Two Prolonged-release Formulations in Healthy Adult Subjects

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Jun 27, 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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