Clinical trial NCT01432535: Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655)
Official title: A Single Dose Study to Assess Pharmacokinetics of SCH 54031 in Patients With Renal Impairment (P05655)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Insufficiency
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-09-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
timeFrame: From hour 0 (pre-dose) to 288 hours post-dose
measure: AUC From Time 0 to the Last Measurable Sample (AUC0-last)
timeFrame: From hour 0 (pre-dose) up to 288 hours post-dose
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: From hour 0 (pre-dose) to 288 hours post-dose
measure: Time to Maximum Observed Serum Concentration (Tmax)
timeFrame: From hour 0 (pre-dose) up to 288 hours post-dose
measure: Apparent Terminal Half-life (T1/2)
timeFrame: From hour 0 (pre-dose) up to 288 hours post-dose
measure: Apparent Total Body Clearance (CL/F)
timeFrame: From hour 0 (pre-dose) up to 288 hours post-dose
measure: Apparent Volume of Distribution (Vd/F)
timeFrame: From hour 0 (pre-dose) up to 288 hours post-dose
Secondary outcomes:
Other outcomes:
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