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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Renal Insufficiency

Treatments: Drug: PegIFN-2b (Sylatron®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01432535

P05655

MK-4031-350 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

Healthy Participants

Active Comparator group

Description:

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.

Treatment:

Drug: PegIFN-2b (Sylatron®)

Participants with Moderate Renal Impairment

Experimental group

Description:

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.

Treatment:

Drug: PegIFN-2b (Sylatron®)

Participants with Severe Renal Impairment

Experimental group

Description:

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.

Treatment:

Drug: PegIFN-2b (Sylatron®)