NCT05077436

Bioavailability Study Comparing 2 Vamifeport Oral Formulations in Fasted Versus Fed State in Healthy Subjects

A Randomised, Open-Label, Food Effect and Formulation Bioavailability Study of Two Vamifeport Oral Formulations in Healthy Male and Female Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Vifor (International) Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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. 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

Interventions

Type	Name	Description
DRUG	Vamifeport Formulation 1	Vamifeport Formulation 1 is available as 60 mg oral capsules
DRUG	Vamifeport Formulation 2	Vamifeport Formulation 2 is available as 60 mg oral capsules

Timeline

• Start date: 2021-10-14
• Primary completion: 2021-12-29
• Completion: 2022-01-05
• First posted: 2021-10-14
• Last updated: 2022-08-17

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study