HealthyPhase 1NCT05077436
Bioavailability Study Comparing 2 Vamifeport Oral Formulations in Fasted Versus Fed State in Healthy Subjects
A Phase 1 study testing Vamifeport Formulation 1 and Vamifeport Formulation 2 in people with Healthy, run by Vifor (International) Inc. at 1 site in United Kingdom.
Trial summary
Two different vamifeport oral formulations will be administered in fed and fasted state to assess the vamifeport food-drug interaction and to assess the relative bioavailability (the proportion of drug entering the circulation) of 2 different vamifeport oral formulations in healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vamifeport Formulation 1 and Vamifeport Formulation 2
- 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
- 14 Oct 2021to 5 Jan 2022
- 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
- Healthy participant. Healthy status defined by the Investigator.
- A body weight between 50 and 100 kg inclusive at screening.
- Non-smokers, or former smokers.
- Both female and male participants must agree to comply with the birth control requirements for the study.
- Ability to understand the requirements of the study and abide by the study restrictions, and agreement to return for the required assessments.
Who cannot join
- History of clinically significant gastrointestinal, cardiovascular, musculoskeletal, endocrine, neurological, hematological, psychiatric, renal, hepatic, bronchopulmonary, allergic or lipid metabolism disorders, cancer, or drug hypersensitivity.
- Any clinically relevant abnormal 12-lead ECG finding during screening or prior to randomization.
- A clinically relevant history of drug or alcohol misuse or abuse within 2 years prior to screening.
- Positive qualitative or semi-quantitative test for drugs of abuse positive cotinine screen (used to detect recent nicotine use), or alcohol breath test at screening (Visit 1) or Study Day -1 (Visit 2). Use of any of these agents will be not permitted during study participation.
- Strenuous physical exercise within the 1 week prior to Visit 2/Study Day -1 admission, and until completion of safety follow-up assessments are completed.
- Female participants who are pregnant or breastfeeding.
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- Any concomitant medication (including herbal remedies and vitamins) taken within 2 weeks prior to Visit 2.
- Concomitant use of hormonal contraceptives (contraception associated with inhibition of ovulation), which are metabolized through cytochrome P450 (CYP) 3A4.
- Any other investigational drug.
- Blood draw or blood donation of ≥20 to <200 ml within 2 weeks, ≥200 to <400 ml within 4 weeks, or ≥400 ml within 12 weeks (male) or within 16 weeks (female) prior to Visit 2.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Labcorp Clinical Research Unit Ltd.
Leeds, LS2 9LH
About this study
Official title: A Randomised, Open-Label, Food Effect and Formulation Bioavailability Study of Two Vamifeport Oral Formulations in Healthy Male and Female Adults
Two different vamifeport oral formulations will be administered in fed and fasted state to assess the vamifeport food-drug interaction and to assess the relative bioavailability (the proportion of drug entering the circulation) of 2 different vamifeport oral formulations in healthy adult participants.
Participants will be randomly allocated to one of four treatment sequences, with four dosing periods each, where different combinations of both formulations will be administered following fasted and fed state.
The total study duration for each participant is up to 7 weeks and 4 days.
- Conditions
- Healthy
- Being tested
- Vamifeport Formulation 1, Vamifeport Formulation 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vamifeport Formulation 1Drug
Vamifeport Formulation 1 is available as 60 mg oral capsules
Vamifeport Formulation 2Drug
Vamifeport Formulation 2 is available as 60 mg oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Participants receive a single dose of study drug, every 4 days:
* Day 1: Participants in fasted state receive Vamifeport Formulation 1
* Day 5: Participants in fed state receive Vamifeport Formulation 1
* Day 9: Participants in fed state receive Vamifeport Formulation 2
* Day 13: Participants in fasted state receive Vamifeport Formulation 2 Receives: Drug: Vamifeport Formulation 1; Drug: Vamifeport Formulation 2 |
| Sequence 2 | Experimental | Participants receive a single dose of study drug, every 4 days:
* Day 1: Participants in fed state receive Vamifeport Formulation 1
* Day 5: Participants in fasted state receive Vamifeport Formulation 2
* Day 9: Participants in fasted state receive Vamifeport Formulation 1
* Day 13: Participants in fed state receive Vamifeport Formulation 2 Receives: Drug: Vamifeport Formulation 1; Drug: Vamifeport Formulation 2 |
| Sequence 3 | Experimental | Participants receive a single dose of study drug, every 4 days:
* Day 1: Participants in fasted state receive Vamifeport Formulation 2
* Day 5: Participants in fed state receive Vamifeport Formulation 2
* Day 9: Participants in fed state receive Vamifeport Formulation 1
* Day 13: Participants in fasted state receive Vamifeport Formulation 1 Receives: Drug: Vamifeport Formulation 1; Drug: Vamifeport Formulation 2 |
| Sequence 4 | Experimental | Participants receive a single dose of study drug, every 4 days:
* Day 1: Participants in fed state receive Vamifeport Formulation 2
* Day 5: Participants in fasted state receive Vamifeport Formulation 1
* Day 9: Participants in fasted state receive Vamifeport Formulation 2
* Day 13: Participants in fed state receive Vamifeport Formulation 1 Receives: Drug: Vamifeport Formulation 1; Drug: Vamifeport Formulation 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-last) of vamifeport
Measured: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Area under the plasma concentration versus time curve from time 0 extrapolated to infinite time (AUC0-infinity) of vamifeport
Measured: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Maximum observed concentration (Cmax) of vamifeport
Measured: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Secondary outcomes (5)
Time of maximum vamifeport plasma concentration (Tmax)
Measured: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Apparent terminal disposition phase half-life (tl/2)
Measured: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Apparent terminal disposition phase rate constant
Measured: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Apparent total clearance
Measured: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Apparent volume of distribution during the terminal disposition phase
Measured: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start14 Oct 2021
- Primary completion29 Dec 2021
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Vifor (International) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Szecsödy, MD, Study director, Clinical Research Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077436
- Sponsor's protocol ID
- VIT-2763-CP-103
- Other IDs
- 2021-003187-27
- Status last verified
- Jan 2022
- First submitted
- 20 Sep 2021
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-Label, Food Effect and Formulation Bioavailability Study of Two Vamifeport Oral Formulations in Healthy Male and Female Adults
- ClinicalTrials.gov ID
- NCT05077436
- Acronym / sponsor ID
- VIT-2763-CP-103
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Vifor (International) Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 14 Oct 2021 (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.
Two different vamifeport oral formulations will be administered in fed and fasted state to assess the vamifeport food-drug interaction and to assess the relative bioavailability (the proportion of drug entering the circulation) of 2 different vamifeport oral formulations in healthy adult participants.
Participants will be randomly allocated to one of four treatment sequences, with four dosing periods each, where different combinations of both formulations will be administered following fasted and fed state.
The total study duration for each participant is up to 7 weeks and 4 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: Vamifeport Formulation 1, Drug: Vamifeport Formulation 2Participants receive a single dose of study drug, every 4 days: * Day 1: Participants in fasted state receive Vamifeport Formulation 1 * Day 5: Participants in fed state receive Vamifeport Formulation 1 * Day 9: Participants in fed state receive Vamifeport Formulation 2 * Day 13: Participants in fasted state receive Vamifeport Formulation 2 |
| Sequence 2 | Experimental | Drug: Vamifeport Formulation 1, Drug: Vamifeport Formulation 2Participants receive a single dose of study drug, every 4 days: * Day 1: Participants in fed state receive Vamifeport Formulation 1 * Day 5: Participants in fasted state receive Vamifeport Formulation 2 * Day 9: Participants in fasted state receive Vamifeport Formulation 1 * Day 13: Participants in fed state receive Vamifeport Formulation 2 |
| Sequence 3 | Experimental | Drug: Vamifeport Formulation 1, Drug: Vamifeport Formulation 2Participants receive a single dose of study drug, every 4 days: * Day 1: Participants in fasted state receive Vamifeport Formulation 2 * Day 5: Participants in fed state receive Vamifeport Formulation 2 * Day 9: Participants in fed state receive Vamifeport Formulation 1 * Day 13: Participants in fasted state receive Vamifeport Formulation 1 |
| Sequence 4 | Experimental | Drug: Vamifeport Formulation 1, Drug: Vamifeport Formulation 2Participants receive a single dose of study drug, every 4 days: * Day 1: Participants in fed state receive Vamifeport Formulation 2 * Day 5: Participants in fasted state receive Vamifeport Formulation 1 * Day 9: Participants in fasted state receive Vamifeport Formulation 2 * Day 13: Participants in fed state receive Vamifeport Formulation 1 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy participant. Healthy status defined by the Investigator.
- A body weight between 50 and 100 kg inclusive at screening.
- Non-smokers, or former smokers.
- Both female and male participants must agree to comply with the birth control requirements for the study.
- Ability to understand the requirements of the study and abide by the study restrictions, and agreement to return for the required assessments.
Key exclusion criteria (10 listed)
- History of clinically significant gastrointestinal, cardiovascular, musculoskeletal, endocrine, neurological, hematological, psychiatric, renal, hepatic, bronchopulmonary, allergic or lipid metabolism disorders, cancer, or drug hypersensitivity.
- Any clinically relevant abnormal 12-lead ECG finding during screening or prior to randomization.
- A clinically relevant history of drug or alcohol misuse or abuse within 2 years prior to screening.
- Positive qualitative or semi-quantitative test for drugs of abuse positive cotinine screen (used to detect recent nicotine use), or alcohol breath test at screening (Visit 1) or Study Day -1 (Visit 2). Use of any of these agents will be not permitted during study participation.
- Strenuous physical exercise within the 1 week prior to Visit 2/Study Day -1 admission, and until completion of safety follow-up assessments are completed.
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 Formulation 1Vamifeport Formulation 1 is available as 60 mg oral capsules | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
| Vamifeport Formulation 2Vamifeport Formulation 2 is available as 60 mg oral capsules | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4 |
Primary outcome
Area under the plasma concentration versus time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-last) of vamifeport
Time frame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Area under the plasma concentration versus time curve from time 0 extrapolated to infinite time (AUC0-infinity) of vamifeport
Time frame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Maximum observed concentration (Cmax) of vamifeport
Time frame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
5 secondary outcomes
Time of maximum vamifeport plasma concentration (Tmax)
Time frame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Apparent terminal disposition phase half-life (tl/2)
Time frame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Apparent terminal disposition phase rate constant
Time frame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Apparent total clearance
Time frame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Apparent volume of distribution during the terminal disposition phase
Time frame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-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 17 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Peter Szecsödy, MD study director
Clinical Research Director
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 Formulation 1 and Vamifeport Formulation 2 in people with Healthy, run by Vifor (International) Inc. 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 5 inclusion and 10 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 17 Aug 2022. 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 versus time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-last) of vamifeport (time frame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-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 17 Aug 2022.