Status:
COMPLETED
Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Renal Insufficiency
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
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
- 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
- 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)
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01432535
Start Date
November 1 2011
End Date
August 1 2012
Last Update
April 7 2017
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