Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655)
Renal Insufficiency
About this trial
This is an interventional treatment trial for Renal Insufficiency
Eligibility Criteria
Inclusion Criteria:
- Body Mass Index (BMI) between 19 to 40 kg/m^2, inclusive
- Moderate renal impairment and severe renal impairment and/or end-stage renal disease (ESRD) who may require hemodialysis and normal renal function
- Free of any clinically significant disease (except those related to renal disease and comorbid conditions) that requires a physician's care and would interfere with the study
- Females of reproductive potential must have used a medically accepted method of contraception for three months prior to screening and must agree to use an accepted contraceptive method during and for two months following the study
- Males must agree to use a medically accepted method of contraception during the trial and for 3 months after the study
Exclusion Criteria:
- Pregnant, intend to become pregnant, or breastfeeding
- Surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
- History of any infectious disease within 4 weeks prior to study drug administration that affects ability to participate in the study
- Positive for hepatitis B surface antigen, and/or for human immunodeficiency virus (HIV) antibodies. Healthy participants positive for hepatitis C antibodies
- Previously received PegIntron®, Sylatron®, and/or Pegasys
- More than 10 cigarettes or equivalent tobacco use per day
- History of malignancy
- Hypothyroidism or hyperthyroidism
- History of depression requiring treatment with psychotherapy or medication
- History of suicidality or at risk of self-harm or harm to others
- History of autoimmune disorder requiring medical therapy
- Immune mediated renal insufficiency
- Removal of a kidney (healthy participants) or functioning renal transplant (participants with renal impairment)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Healthy Participants
Participants with Moderate Renal Impairment
Participants with Severe Renal Impairment
Participants with normal renal function defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.