A Phase 1 interventional study of Vamifeport IRF and Vamifeport PR1 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 2025-06-27.
Sponsored by CSL Behring (part of CSL Limited) · Phase 1, Interventional, and Other
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.
156 studies on the registry are indexed under Iron Overload; 6 are open to participants now.
This study's enrollment of 22 is below the median of 60 across 97 interventional studies indexed under Iron Overload.
Browse Iron Overload studies →CSL Behring is the lead sponsor of 145 studies on the registry; 17 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.
First submitted after CSL Behring became part of CSL Limited.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive multiple doses of Vamifeport Immediate-release (IR) formulation at Dose level 1.
Drug: Vamifeport IRF
Participants will receive multiple doses of Vamifeport Prolonged-release formulation 1 (PR1) at Dose level 2.
Drug: Vamifeport PR1
Participants will receive multiple doses of Vamifeport Prolonged-release formulation 2 (PR2) at Dose level 2.
Drug: Vamifeport PR2
Participants will receive a single dose of Vamifeport PR1 at Dose level 3.
Drug: Vamifeport PR1
Participants will receive a single dose of Vamifeport PR2 at Dose level 3.
Drug: Vamifeport PR2
Participants will receive a single dose of Vamifeport PR1 at Dose level 3.
Drug: Vamifeport PR1
Participants will receive a single dose of Vamifeport PR2 at Dose level 3.
Drug: Vamifeport PR2
Vamifeport IRF will be administered orally as per the dosing levels and formulations for respective treatment periods.
Also known as: CSL624
Vamifeport PR1 will be administered orally as per the dosing levels and formulations for respective treatment periods.
Also known as: CSL624
Vamifeport PR2 will be administered orally as per the dosing levels and formulations for respective treatment periods.
Also known as: CSL624
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Percentage of participants with TEAE, AE by severity, AE related to vamifeport, and serious AE
Time frame: Up to 25 days after treatment
Number of participants with clinically significant change from Baseline in clinical laboratory safety tests, 12 lead Electrocardiogram (ECG), and vital signs
The clinical laboratory safety tests include biochemistry, hematology, urinalysis.
Time frame: At baseline and up to 25 days after treatment
AUC0-24 of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Comparison of AUC0-24 between PR1 and PR2
Time frame: Before and up to 24 hours after dosing, in TP3 and TP4
AUC0-12 of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Comparison of AUC0-12 between PR1 and PR2
Time frame: Before and up to 12 hours after dosing, in TP3 and TP4
AUC0-inf of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Comparison of AUC0-inf between PR1 and PR2
Time frame: Before and up to 48 hours after dosing, in TP3 and TP4
Conc (t=12) of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Comparison of conc(t=12) between PR1 and PR2
Time frame: Before and up to 12 hours after dosing, in TP3 and TP4
Conc (t=24) of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Comparison of conc(t=24) between PR1 and PR2
Time frame: Before and up to 24 hours after dosing, in TP3 and TP4
Cmax of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Comparison of cmax between PR1 and PR2
Time frame: Before and up to 48 hours after dosing, in TP3 and TP4
Tmax of vamifeport PR1 and PR2 in Treatment Period 3 and 4
Comparison of tmax between PR1 and PR2
Time frame: Before and up to 48 hours after dosing, in TP3 and TP4
Absolute values of serum iron
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Absolute values of transferrin saturation (TSAT)
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Change from baseline of serum iron
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Change from baseline of TSAT
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Maximum percentage change from baseline (Emax) of serum iron
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Emax of TSAT
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Time to Emax (TEmax) of serum iron
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
TEmax of TSAT
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Time below baseline of serum iron
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
Time below baseline of TSAT
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
AUC below baseline of serum iron
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
AUC below baseline of TSAT
Time frame: Before and up to 48 hours after dosing in TP2, TP3 and TP4
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, Statistical analysis plan
Time frame: Requests for IPD will generally be considered once review by major regulatory authorities (i.e. FDA, EMA) is complete and the primary publication is available
Access criteria: Proposed research should seek to answer a previously unanswered important medical or scientific question. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
No publications or documents are linked to this record.
Ran from Nov 2024 to primary completion in Jan 2025, 2 months.
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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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