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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01432535
First Posted: September 13, 2011
Last Update Posted: April 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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.

Condition Intervention Phase
Renal Insufficiency Drug: PegIFN-2b (Sylatron®) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single Dose Study to Assess Pharmacokinetics of SCH 54031 in Patients With Renal Impairment (P05655)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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%.

  • 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).

  • 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.


Enrollment: 25
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: PegIFN-2b (Sylatron®)
Single 4.5 μg/kg dose
Other Names:
  • PegIntron®
  • Peginterferon alfa-2b
  • SCH 054031
  • MK-4031
Experimental: 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.
Drug: PegIFN-2b (Sylatron®)
Single 4.5 μg/kg dose
Other Names:
  • PegIntron®
  • Peginterferon alfa-2b
  • SCH 054031
  • MK-4031
Experimental: 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.
Drug: PegIFN-2b (Sylatron®)
Single 4.5 μg/kg dose
Other Names:
  • PegIntron®
  • Peginterferon alfa-2b
  • SCH 054031
  • MK-4031

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01432535     History of Changes
Other Study ID Numbers: P05655
MK-4031-350 ( Other Identifier: Merck protocol number )
First Submitted: September 9, 2011
First Posted: September 13, 2011
Results First Submitted: July 23, 2013
Results First Posted: September 25, 2013
Last Update Posted: April 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs