Phase 1
N=25
Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655)
Renal Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT01432535 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
Sep 2013
Primary outcome: Primary: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) — 305315.22; 435500.38; 658413.69 pg*hr/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- PegIFN-2b (Sylatron®) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) |
305315.22; 435500.38; 658413.69 | — |
| PRIMARY AUC From Time 0 to the Last Measurable Sample (AUC0-last) |
286946.43; 408889.84; 598863.88 | — |
| PRIMARY Maximum Observed Serum Concentration (Cmax) |
2547.85; 3210.16; 3551.03 | — |
| PRIMARY Time to Maximum Observed Serum Concentration (Tmax) |
12.0; 12.0; 60.0 | — |
| PRIMARY Apparent Terminal Half-life (T1/2) |
41.9; 50.7; 58.1 | — |
| PRIMARY Apparent Total Body Clearance (CL/F) |
18.5; 12.72; 8.02 | — |
| PRIMARY Apparent Volume of Distribution (Vd/F) |
90.63; 72.26; 55.90 | — |
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)
Data sourced from ClinicalTrials.gov (NCT01432535). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.