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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Vamifeport Formulation 1; Drug: Vamifeport Formulation 2

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9LH
    • Labcorp Clinical Research Unit Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy participant. Healthy status defined by the Investigator.
• A body weight between 50 and 100 kg inclusive at screening.
• Non-smokers, or former smokers.
• Both female and male participants must agree to comply with the birth control requirements for the study.
• Ability to understand the requirements of the study and abide by the study restrictions, and agreement to return for the required assessments.

Exclusion Criteria:

• History of clinically significant gastrointestinal, cardiovascular, musculoskeletal, endocrine, neurological, hematological, psychiatric, renal, hepatic, bronchopulmonary, allergic or lipid metabolism disorders, cancer, or drug hypersensitivity.
• Any clinically relevant abnormal 12-lead ECG finding during screening or prior to randomization.
• A clinically relevant history of drug or alcohol misuse or abuse within 2 years prior to screening.
• Positive qualitative or semi-quantitative test for drugs of abuse positive cotinine screen (used to detect recent nicotine use), or alcohol breath test at screening (Visit 1) or Study Day -1 (Visit 2). Use of any of these agents will be not permitted during study participation.
• Strenuous physical exercise within the 1 week prior to Visit 2/Study Day -1 admission, and until completion of safety follow-up assessments are completed.
• Female participants who are pregnant or breastfeeding.
• Any concomitant medication (including herbal remedies and vitamins) taken within 2 weeks prior to Visit 2.
• Concomitant use of hormonal contraceptives (contraception associated with inhibition of ovulation), which are metabolized through cytochrome P450 (CYP) 3A4.
• Any other investigational drug.
• Blood draw or blood donation of ≥20 to <200 ml within 2 weeks, ≥200 to <400 ml within 4 weeks, or ≥400 ml within 12 weeks (male) or within 16 weeks (female) prior to Visit 2.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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
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	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
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	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
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration versus time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-last) of vamifeport	Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Area under the plasma concentration versus time curve from time 0 extrapolated to infinite time (AUC0-infinity) of vamifeport	Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Maximum observed concentration (Cmax) of vamifeport	Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Time of maximum vamifeport plasma concentration (Tmax)	Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Apparent terminal disposition phase half-life (tl/2)	Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Apparent terminal disposition phase rate constant	Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Apparent total clearance	Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose
Apparent volume of distribution during the terminal disposition phase	Day 1, Day 5, Day 9, Day 13: 0-24 hours post-dose

Collaborators and Investigators

• Sponsor: Vifor (International) Inc.
• Investigators: Study Director: Peter Szecsödy, MD, Clinical Research Director

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2021
• Primary Completion (Actual): December 29, 2021
• Study Completion (Actual): January 5, 2022

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 30, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: VIT-2763-CP-103; 2021-003187-27 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No