Healthy VolunteersPhase 1NCT06996184
Effect of Food on the Oral Bioavailability of a Prolonged-release Formulation of Vamifeport in Healthy Adults
A Phase 1 study testing Vamifeport (PR formulation) in people with Healthy Volunteers, run by CSL Behring at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Vamifeport (PR formulation)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 May 2025to 4 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- •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.
Who cannot join
- •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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Investigator Site 82600083
Leeds, West Yorkshire, LS11 9E
About this study
Official 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
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.
- Conditions
- Healthy Volunteers
- Being tested
- Vamifeport (PR formulation)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vamifeport (PR formulation)Drug
Also called CSL624
Vamifeport will be administered orally
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Vamifeport Fasted then Fed | Experimental | 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. Receives: Drug: Vamifeport (PR formulation) |
| Sequence 2: Vamifeport Fed then Fasted | Experimental | 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. Receives: Drug: Vamifeport (PR formulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of vamifeport
Measured: 0-96 hours after dose
AUC from time zero extrapolated to infinity (AUC0-inf) of vamifeport
Measured: 0-96 hours after dose
Maximum observed plasma concentration (Cmax) of vamifeport
Measured: 0-96 hours after dose
Secondary outcomes (14)
Number of participants with treatment emergent adverse events (TEAEs) overall, by severity, seriousness, and relationship to vamifeport
Measured: Up to Day 13 (+/- 2 days)
Percentage of participants with TEAEs overall, by severity, seriousness, and relationship to vamifeport
Measured: 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
Measured: 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
Measured: Up to Day 13 (+/- 2 days)
Time of the maximum observed plasma concentration (Tmax) of vamifeport
Measured: 0-96 hours after dose
Apparent terminal disposition phase plasma half life (t1/2) of vamifeport
Measured: 0-96 hours after dose
Apparent terminal disposition rate constant (λz) of vamifeport
Measured: 0-96 hours after dose
Apparent total clearance (CL/F) of vamifeport
Measured: 0-96 hours after dose
Apparent volume of distribution (V/F) of vamifeport
Measured: 0-96 hours after dose
Percentage of AUC due to extrapolation from the last quantifiable concentration to infinity (%AUCextrap) of vamifeport
Measured: 0-96 hours after dose
Time of the last quantifiable concentration (Tlast) of vamifeport
Measured: 0-96 hours after dose
The time taken for vamifeport to appear in the systemic circulation following administration (Tlag), when applicable
Measured: 0-96 hours after dose
AUC from time zero to 12 hours (AUC0-12) and 24 hours (AUC0-24) of vamifeport
Measured: 0-12 hours post-dose and 0-24 hours after dose
Plasma concentration of vamifeport
Measured: At 12 hours and 24 hours after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start27 May 2025
- Primary completion1 Jul 2025
- Study completion4 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996184
- Sponsor's protocol ID
- CSL624_1006
- Status last verified
- Nov 2025
- First submitted
- 21 May 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06996184
- Acronym / sponsor ID
- CSL624_1006
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 27 May 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 4 Jul 2025 (actual)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Vamifeport Fasted then Fed | Experimental | Drug: 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 | Experimental | 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- •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.
Key exclusion criteria (4 listed)
- •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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vamifeport (PR formulation)Also: CSL624Vamifeport will be administered orally | Drug | Sequence 1: Vamifeport Fasted then Fed, Sequence 2: Vamifeport Fed then Fasted |
Primary outcome
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
14 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
CSL Behring
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vamifeport (PR formulation) in people with Healthy Volunteers, run by CSL Behring at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.