An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild, Moderate, Severe, or No Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: Deferiprone
Intervention description: Oral iron chelator
Intervention MeSH terms: Deferiprone
Phase: Phase 4
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Renal Impairment; Kidney Impairment; Kidney Disease; Ferriprox; Deferiprone; DFP (deferiprone); L1

Summary:

      Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the
      effect of impaired renal function on the PK of deferiprone and its 3-O-glucuronide metabolite
      following a single oral dose of 33mg/kg Ferriprox®.
    

Eligibility criteria:

        Main Inclusion Criteria:

        All subjects:

          1. Adult males or females, 18 - 75 years of age (inclusive);

          2. Body weight ≥ 45 kg;

          3. Body mass index (BMI) range of approximately 18.5-32 kg/m^2 (inclusive);

          4. Absolute neutrophil count (ANC) of >1.5x10^9/L;

        Healthy volunteers:

          1. Medically healthy with clinically insignificant screening results (e.g., laboratory
             profiles, medical history, vital signs, physical examination);

          2. eGFR ≥ 90 mL/min/1.73m^2;

        Renally impaired subjects:

          1. Considered clinically stable in the opinion of the Investigator;

          2. Subjects with mild renal impairment (eGFR 60-89 mL/min/1.73m^E2) OR moderate renal
             impairment (eGFR 30-59 mL/min/1.73m^2) OR severe renal impairment (eGFR 15-29
             mL/min/1.73m^2).

        Main Exclusion Criteria:

          1. History of renal transplant;

          2. Subjects undergoing any method of dialysis;

          3. History or presence of clinically unstable significant respiratory, cardiovascular,
             pulmonary, hepatic, renal (except for subjects assigned to one of the renally impaired
             groups), hematologic, gastrointestinal, endocrine, immunologic, dermatologic,
             neurologic, or psychiatric disease;

          4. Disorders or surgery of the gastrointestinal tract which may interfere with drug
             absorption or may otherwise influence the PK of the investigational medicinal product
             (e.g. cholecystectomy, resections of the small or large intestine, febrile conditions,
             chronic diarrhea, chronic vomiting, endocrine disease, severe infections, acute
             inflammations, etc.);

          5. Clinically significant abnormalities on 12-lead ECG (e.g., QTcF≥430 ms in males or
             ≥450 ms in females);

          6. Evidence of liver damage: hepatitis B and C; aspartate aminotransferase (AST), alanine
             aminotransferase (ALT) that is considered clinically significant by the Investigator;

          7. Participation in another clinical trial within 28 days prior to the study drug
             administration;