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

NCT ID: NCT05077436

Last Updated: 2022-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-14
• Study Completion Date: 2022-01-05

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Vamifeport Formulation 1

Intervention Type: DRUG

Vamifeport Formulation 1 is available as 60 mg oral capsules

Vamifeport Formulation 2

Intervention Type: DRUG

Vamifeport Formulation 2 is available as 60 mg oral capsules

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

Group Type: EXPERIMENTAL

Vamifeport Formulation 1

Intervention Type: DRUG

Vamifeport Formulation 1 is available as 60 mg oral capsules

Vamifeport Formulation 2

Intervention Type: DRUG

Vamifeport Formulation 2 is available as 60 mg oral capsules

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

Group Type: EXPERIMENTAL

Vamifeport Formulation 1

Intervention Type: DRUG

Vamifeport Formulation 1 is available as 60 mg oral capsules

Vamifeport Formulation 2

Intervention Type: DRUG

Vamifeport Formulation 2 is available as 60 mg oral capsules

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

Group Type: EXPERIMENTAL

Vamifeport Formulation 1

Intervention Type: DRUG

Vamifeport Formulation 1 is available as 60 mg oral capsules

Vamifeport Formulation 2

Intervention Type: DRUG

Vamifeport Formulation 2 is available as 60 mg oral capsules

Interventions

Vamifeport Formulation 1

Vamifeport Formulation 1 is available as 60 mg oral capsules

Intervention Type: DRUG

Vamifeport Formulation 2

Vamifeport Formulation 2 is available as 60 mg oral capsules

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vifor (International) Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Szecsödy, MD

Role: STUDY_DIRECTOR

Clinical Research Director

Locations

Labcorp Clinical Research Unit Ltd.

Leeds, , United Kingdom

Countries

United Kingdom

Other Identifiers

2021-003187-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VIT-2763-CP-103

Identifier Type: -

Identifier Source: org_study_id