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

Sponsor

Vifor (International) Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT05077436

Collaborator

(none)

Enrollment

Location

Arms

2.7

Actual Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Vamifeport Formulation 1 Drug: Vamifeport Formulation 2	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 14, 2021

Actual Primary Completion Date :

Dec 29, 2021

Actual Study Completion Date :

Jan 5, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Labcorp Clinical Research Unit Ltd.	Leeds		United Kingdom	LS2 9LH

Sponsors and Collaborators

Vifor (International) Inc.

Investigators

Study Director: Peter Szecsödy, MD, Clinical Research Director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vifor (International) Inc.

ClinicalTrials.gov Identifier:

NCT05077436

Other Study ID Numbers:

VIT-2763-CP-103
2021-003187-27

First Posted:

Oct 14, 2021

Last Update Posted:

Aug 17, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 17, 2022