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

• Status: Completed
• Trial end date: 2018-08-07
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to assess whether renal impairment could affect fevipiprant pharmacokinetics (PK) to the extent that dosage adjustment is appropriate for this patient population.

The study also aims to determine the effect of dialysis on the fevipiprant pharmacokinetic profile as the procedure might remove a significant fraction of the drug.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Indoleacetic Acids

Criteria

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)