Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655)

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the pharmacokinetics of a single dose of peginterferon alfa-2b (Sylatron®) in healthy participants to that in participants with moderate to severe impairment of kidney function.

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

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Interferon-alpha; Peginterferon alfa-2b

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)