Pharmacokinetics and Safety of Fevipiprant in Patients With Renal Impairment Compared to Matched Healthy Subjects

The purpose of this study is to determine if the pharmacokinetic profile of fevipiprant is different in patients with renal impariment compared to healthy matched volunteers to an extent that would require an adjustment of the dosage. Data from this study will be used to guide enrollment criteria in future clinical trials and to support regulatory submission and labeling information

Inclusion criteria

• Healthy subjects must satisfy the criteria for normal renal function as evidenced by normal Glomerular Filtration Rate (GFR): eGFR ≥ 90 mL/min/1.73m2; each healthy subject must match in age (+/- 10years), gender, smoking status, and weight (+/- 15%), a patient from the renail impaired patient groups:
• A body mass index (BMI) within the range of 18 - 36 kg/m2
• ESRD patients on hemodialysis: an glomerulo filtration rat GFR of < 15 mL/min/1.73 m2
• patients with severe renal impairment: GFR of< 30 mL/min/1.73m2 (without need of hemodialysis);
• patients with moderate renal impairment: 30 mL/min/1.73m2 ≤ eGFR < 60 mL/min/1.73m2;
• patients with mild impairment: 60 mL/min/1.73m2 ≤ eGFR < 90 mL/min/1.73m2

Exclusion criteria

• Pregnant or nursing (lactating) women
• History or evidence of any inherited bilirubin disease or disorder
• subjects participating in another study
• malignancies in the past
• Hemoglobin levels below 10 g/dL at screening
• HIV positiv
• Heavy smokers (≥20 cigarettes per day)
• Liver disease, as indicated by ALT, γ-GT, AST and alkaline phosphatase which should not exceed twice the upper limit of normal and should be stable (e.g. increased liver values known from previous patient records). Serum bilirubin > 27 μmol/L (1.6 mg/dL)
• Clinically significant ECG changes and/or arrhythmias
• Chronic infection with Hepatitis B (HBV) or Hepatitis C (HCV)