Healthy volunteers Other
Conditions
Interventions
1. Inform potential participants about the study and obtain their informed consent to participate
2. Include participants in the study based on the inclusion and exclusion criteria
3. Assessments duri
Sponsors
Vifor (International) Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Males, of any race, between 35 and 65 years of age, inclusive 2. Body mass index between 18.0 and 30.0 kg/m2, inclusive 3. In good health, determined by no clinically significant findings from medical history, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations (anaemia, congenital nonhaemolytic hyperbilirubinemia, e.g., suspicion of Gilbert’s syndrome based on total and direct bilirubin, is not acceptable) at screening and checkin and from the physical examination at check-in, as assessed by the Investigator (or designee) 4. Males will agree to use contraception 5. Able to comprehend and willing to sign an ICF and to abide by the study restrictions 6. History of a minimum of 1 bowel movement per day
Exclusion criteria
Exclusion criteria: 1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular (history of clinically relevant ECG findings [e.g., Torsades de Points, cardiac arrhythmia, cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT-syndrome, family history of sudden death]), gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee). 2. Any clinically relevant abnormal 12-lead ECG finding at screening and/or check-in, as determined by the Investigator (or designee), including, but not limited to, any of the following: 2.1. PR interval >210 ms or 112 ms 3. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) 4. Serum ferritin 300 ng/ml at screening 5. Haemoglobin <13 g/dl (8.1 mmol/l) at screening and/or check-in 6. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed) 7. Positive hepatitis panel and/or positive human immunodeficiency virus test 8. Subjects with estimated glomerular filtration rate <90 ml/min/1.73m² calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation with serum creatinine at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recovery of total radioactivity - amount of dose administered recovered in urine (Ae) and urine (fe), faeces, and total excreta (urine + faeces), derived from urine and faeces analysis, up to Day 28 2. PK parameters including AUC0-infinity, AUC0-last, Cmax, Tmax, and T1/2 for Vamifeport in plasma and total radioactivity in plasma and whole blood as well as urinary recovery of Vamifeport (Ae and fe) and CLr, derived from plasma, blood, and urine analysis, up to Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Further PK parameters, such as apparent terminal disposition phase rate constant, apparent total clearance, apparent volume distribution during the terminal disposition phase, and blood to plasma ratios; additional PK parameters may be calculated where appropriate, derived from plasma, blood, and urine analysis, up to Day 7 2. Quantitative metabolic profiles of Vamifeport in plasma and excreta, derived from plasma and excreta analysis, up to Day 7 3. Identification of Vamifeport major metabolites in plasma (>10% relative total drug exposure) and excreta (>10% of excreted dose), derived from plasma and excreta analysis, up to Day 7 4. Incidence and severity of AEs, collected from the signing of the informed consent form to final discharge of the study, up to Day 28 5. Incidence of laboratory abnormalities, based on haematology, clinical chemistry, and urinalysis test results, derived from blood and urine analysis, up to Day 14 6. 12-lead ECG parameters, assessed by the Investigator or designee during the study, up to Day 14 7. Vital signs measurements, assessed by the Investigator or designee during the study, up to Day 14 | — |
Countries
England, United Kingdom
Contacts
Public ContactClinical trial scientific and public contact
Outcome results
None listed