drugset / Trial / NCT05077436

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

NCT05077436 ↗

Phase 1 Completed 28 enrolled Vifor (International) Inc.
RandomizedCrossoverOpen-labelOther

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.

Timeline

Start
2021-10-14
Primary completion
2021-12-29
Completion
2022-01-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Vamifeport Small molecule 60 mg Oral

Indications

No indication recorded.