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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003187-27 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Participants receive a single dose of study drug, every 4 days:
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| Sequence 2 | Experimental | Participants receive a single dose of study drug, every 4 days:
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| Sequence 3 | Experimental | Participants receive a single dose of study drug, every 4 days:
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| Sequence 4 | Experimental | Participants receive a single dose of study drug, every 4 days:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vamifeport Formulation 1 | Drug | Vamifeport Formulation 1 is available as 60 mg oral capsules |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-last) of vamifeport | 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 | Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose | |
| Maximum observed concentration (Cmax) of vamifeport | Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time of maximum vamifeport plasma concentration (Tmax) | Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose | |
| Apparent terminal disposition phase half-life (tl/2) | Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Szecsödy, MD | Clinical Research Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Labcorp Clinical Research Unit Ltd. | Leeds | LS2 9LH | United Kingdom |
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| Vamifeport Formulation 2 | Drug | Vamifeport Formulation 2 is available as 60 mg oral capsules |
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| Apparent terminal disposition phase rate constant | Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose |
| Apparent total clearance | Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose |
| Apparent volume of distribution during the terminal disposition phase | Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose |