Skip to main content
OpenTrials
Completed

NCT Number: NCT01432535

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PegIFN-2b (Sylatron®)

Drug

Single 4.5 μg/kg dose

Other names: PegIntron®, Peginterferon alfa-2b, SCH 054031, MK-4031

Primary outcomes

  1. Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)

    Time frame: From hour 0 (pre-dose) to 288 hours post-dose

    AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.

  2. AUC From Time 0 to the Last Measurable Sample (AUC0-last)

    Time frame: From hour 0 (pre-dose) up to 288 hours post-dose

    AUC0-last is a measure of the total amount of drug in the plasma from the dose to the last measurable sample.

  3. Maximum Observed Serum Concentration (Cmax)

    Time frame: From hour 0 (pre-dose) to 288 hours post-dose

    Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.

  4. Time to Maximum Observed Serum Concentration (Tmax)

    Time frame: From hour 0 (pre-dose) up to 288 hours post-dose

    Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.

  5. Apparent Terminal Half-life (T1/2)

    Time frame: From hour 0 (pre-dose) up to 288 hours post-dose

    T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.

  6. Apparent Total Body Clearance (CL/F)

    Time frame: From hour 0 (pre-dose) up to 288 hours post-dose

    CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).

  7. Apparent Volume of Distribution (Vd/F)

    Time frame: From hour 0 (pre-dose) up to 288 hours post-dose

    Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Single Dose Study to Assess Pharmacokinetics of SCH 54031 in Patients With Renal Impairment (P05655)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 13, 2011
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.