Status:
COMPLETED
Effect of Food on the Oral Bioavailability of a Prolonged-release Formulation of Vamifeport in Healthy Adults
Lead Sponsor:
CSL Behring
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief 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)...
Eligibility Criteria
Inclusion
- •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.
Exclusion
- •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.
Key Trial Info
Start Date :
May 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06996184
Start Date
May 27 2025
End Date
July 4 2025
Last Update
November 21 2025
Active Locations (1)
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1
Investigator Site 82600083
Leeds, West Yorkshire, United Kingdom, LS11 9E