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

Sponsor
Vifor (International) Inc.
Study ID
NCT05077436
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 14, 2021
Status verified
Jan 2022
Primary completion
Dec 29, 2021
Completion
Jan 5, 2022

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Sequence 1
    Participants receive a single dose of study drug, every 4 days: * Day 1: Participants in fasted state receive Vamifeport Formulation 1 * Day 5: Participants in fed state receive Vamifeport Formulation 1 * Day 9: Participants in fed state receive Vamifeport Formulation 2 * Day 13: Participants in fasted state receive Vamifeport Formulation 2
  • Experimental: Sequence 2
    Participants receive a single dose of study drug, every 4 days: * Day 1: Participants in fed state receive Vamifeport Formulation 1 * Day 5: Participants in fasted state receive Vamifeport Formulation 2 * Day 9: Participants in fasted state receive Vamifeport Formulation 1 * Day 13: Participants in fed state receive Vamifeport Formulation 2
  • Experimental: Sequence 3
    Participants receive a single dose of study drug, every 4 days: * Day 1: Participants in fasted state receive Vamifeport Formulation 2 * Day 5: Participants in fed state receive Vamifeport Formulation 2 * Day 9: Participants in fed state receive Vamifeport Formulation 1 * Day 13: Participants in fasted state receive Vamifeport Formulation 1
  • Experimental: Sequence 4
    Participants receive a single dose of study drug, every 4 days: * Day 1: Participants in fed state receive Vamifeport Formulation 2 * Day 5: Participants in fasted state receive Vamifeport Formulation 1 * Day 9: Participants in fasted state receive Vamifeport Formulation 2 * Day 13: Participants in fed state receive Vamifeport Formulation 1

Primary Outcome Measure

Area under the plasma concentration versus time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-last) of vamifeport [ Time Frame: Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose ]

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