Investigator Site 82600083
Leeds, West Yorkshire, LS11 9E, United Kingdom
NCT Number: NCT06996184
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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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Leeds, West Yorkshire, LS11 9E, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Vamifeport will be administered orally
Other names: CSL624
Time frame: 0-96 hours after dose
Time frame: 0-96 hours after dose
Time frame: 0-96 hours after dose
Time frame: Up to Day 13 (+/- 2 days)
Time frame: Up to Day 13 (+/- 2 days)
Time frame: Up to Day 13 (+/- 2 days)
Time frame: Up to Day 13 (+/- 2 days)
Time frame: 0-96 hours after dose
Time frame: 0-96 hours after dose
Time frame: 0-96 hours after dose
Time frame: 0-96 hours after dose
Time frame: 0-96 hours after dose
Time frame: 0-96 hours after dose
Time frame: 0-96 hours after dose
Time frame: 0-96 hours after dose
Time frame: 0-12 hours post-dose and 0-24 hours after dose
Time frame: At 12 hours and 24 hours after dose
CSL Behring
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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