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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vamifeport (PR formulation) | Drug | Vamifeport will be administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of vamifeport | 0-96 hours after dose | |
| AUC from time zero extrapolated to infinity (AUC0-inf) of vamifeport | 0-96 hours after dose | |
| Maximum observed plasma concentration (Cmax) of vamifeport | 0-96 hours after dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent adverse events (TEAEs) overall, by severity, seriousness, and relationship to vamifeport | Up to Day 13 (+/- 2 days) | |
| Percentage of participants with TEAEs overall, by severity, seriousness, and relationship to vamifeport |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site 82600083 | Leeds | West Yorkshire | LS11 9E | United Kingdom |
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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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.
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|
| 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 | 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 | Up to Day 13 (+/- 2 days) |
| Time of the maximum observed plasma concentration (Tmax) of vamifeport | 0-96 hours after dose |
| Apparent terminal disposition phase plasma half life (t1/2) of vamifeport | 0-96 hours after dose |
| Apparent terminal disposition rate constant (λz) of vamifeport | 0-96 hours after dose |
| Apparent total clearance (CL/F) of vamifeport | 0-96 hours after dose |
| Apparent volume of distribution (V/F) of vamifeport | 0-96 hours after dose |
| Percentage of AUC due to extrapolation from the last quantifiable concentration to infinity (%AUCextrap) of vamifeport | 0-96 hours after dose |
| Time of the last quantifiable concentration (Tlast) of vamifeport | 0-96 hours after dose |
| The time taken for vamifeport to appear in the systemic circulation following administration (Tlag), when applicable | 0-96 hours after dose |
| AUC from time zero to 12 hours (AUC0-12) and 24 hours (AUC0-24) of vamifeport | 0-12 hours post-dose and 0-24 hours after dose |
| Plasma concentration of vamifeport | At 12 hours and 24 hours after dose |