A Phase 1 interventional study of Vamifeport (PR formulation) in Healthy Volunteers, sponsored by CSL Behring. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by CSL Behring · Phase 1, Interventional, and Other
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.
CSL Behring is the lead sponsor of 142 studies on the registry; 18 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: 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.
Drug: Vamifeport (PR formulation)
Vamifeport will be administered orally
Also known as: CSL624
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
AUC from time zero extrapolated to infinity (AUC0-inf) of vamifeport
Time frame: 0-96 hours after dose
Maximum observed plasma concentration (Cmax) of vamifeport
Time frame: 0-96 hours after dose
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)
Percentage of participants with TEAEs overall, by severity, seriousness, and relationship to vamifeport
Time frame: 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
Time frame: 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
Time frame: Up to Day 13 (+/- 2 days)
Time of the maximum observed plasma concentration (Tmax) of vamifeport
Time frame: 0-96 hours after dose
Apparent terminal disposition phase plasma half life (t1/2) of vamifeport
Time frame: 0-96 hours after dose
Apparent terminal disposition rate constant (λz) of vamifeport
Time frame: 0-96 hours after dose
Apparent total clearance (CL/F) of vamifeport
Time frame: 0-96 hours after dose
Apparent volume of distribution (V/F) of vamifeport
Time frame: 0-96 hours after dose
Percentage of AUC due to extrapolation from the last quantifiable concentration to infinity (%AUCextrap) of vamifeport
Time frame: 0-96 hours after dose
Time of the last quantifiable concentration (Tlast) of vamifeport
Time frame: 0-96 hours after dose
The time taken for vamifeport to appear in the systemic circulation following administration (Tlag), when applicable
Time frame: 0-96 hours after dose
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
Plasma concentration of vamifeport
Time frame: At 12 hours and 24 hours after dose
Plan to share: Yes — CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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