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

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.