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

Vifor

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Vamifeport Formulation 2; Drug: Vamifeport Formulation 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05077436

VIT-2763-CP-103

2021-003187-27 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

Sequence 1

Experimental group

Description:

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

Treatment:

Drug: Vamifeport Formulation 1

Drug: Vamifeport Formulation 2

Sequence 2

Experimental group

Description:

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

Treatment:

Drug: Vamifeport Formulation 1

Drug: Vamifeport Formulation 2

Sequence 3

Experimental group

Description:

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

Treatment:

Drug: Vamifeport Formulation 1

Drug: Vamifeport Formulation 2

Sequence 4

Experimental group

Description:

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

Treatment:

Drug: Vamifeport Formulation 1

Drug: Vamifeport Formulation 2