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

NCT05077436 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-08-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Vifor (International) Inc.

    lead INDUSTRY

Principal Investigators

  • Peter Szecsödy, MD · Clinical Research Director

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2021-12-29
Completion
2022-01-05
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05077436 on ClinicalTrials.gov