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

NCT ID: NCT01432535

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-08-31

Brief 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.

Conditions

Renal Insufficiency

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy Participants

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.

Group Type: ACTIVE_COMPARATOR

PegIFN-2b (Sylatron®)

Intervention Type: DRUG

Single 4.5 μg/kg dose

Participants with Moderate Renal Impairment

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.

Group Type: EXPERIMENTAL

PegIFN-2b (Sylatron®)

Intervention Type: DRUG

Single 4.5 μg/kg dose

Participants with Severe Renal Impairment

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.

Group Type: EXPERIMENTAL

PegIFN-2b (Sylatron®)

Intervention Type: DRUG

Single 4.5 μg/kg dose

Interventions

PegIFN-2b (Sylatron®)

Single 4.5 μg/kg dose

Intervention Type: DRUG

Other Intervention Names

PegIntron®; Peginterferon alfa-2b; SCH 054031; MK-4031

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MK-4031-350

Identifier Type: OTHER

Identifier Source: secondary_id

P05655

Identifier Type: -

Identifier Source: org_study_id