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

Primary Purpose

Renal Insufficiency

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
PegIFN-2b (Sylatron®)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Insufficiency

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Healthy Participants

    Participants with Moderate Renal Impairment

    Participants with Severe Renal Impairment

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
    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)
    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)
    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)
    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)
    T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.
    Apparent Total Body Clearance (CL/F)
    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)
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 9, 2011
    Last Updated
    March 9, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01432535
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2011 (undefined)
    Primary Completion Date
    August 2012 (Actual)
    Study Completion Date
    August 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Insufficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy Participants
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Participants with Moderate Renal Impairment
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Participants with Severe Renal Impairment
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    PegIFN-2b (Sylatron®)
    Other Intervention Name(s)
    PegIntron®, Peginterferon alfa-2b, SCH 054031, MK-4031
    Intervention Description
    Single 4.5 μg/kg dose
    Primary Outcome Measure Information:
    Title
    Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
    Description
    AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.
    Time Frame
    From hour 0 (pre-dose) to 288 hours post-dose
    Title
    AUC From Time 0 to the Last Measurable Sample (AUC0-last)
    Description
    AUC0-last is a measure of the total amount of drug in the plasma from the dose to the last measurable sample.
    Time Frame
    From hour 0 (pre-dose) up to 288 hours post-dose
    Title
    Maximum Observed Serum Concentration (Cmax)
    Description
    Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
    Time Frame
    From hour 0 (pre-dose) to 288 hours post-dose
    Title
    Time to Maximum Observed Serum Concentration (Tmax)
    Description
    Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.
    Time Frame
    From hour 0 (pre-dose) up to 288 hours post-dose
    Title
    Apparent Terminal Half-life (T1/2)
    Description
    T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.
    Time Frame
    From hour 0 (pre-dose) up to 288 hours post-dose
    Title
    Apparent Total Body Clearance (CL/F)
    Description
    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).
    Time Frame
    From hour 0 (pre-dose) up to 288 hours post-dose
    Title
    Apparent Volume of Distribution (Vd/F)
    Description
    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.
    Time Frame
    From hour 0 (pre-dose) up to 288 hours post-dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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)

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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

    Learn more about this trial

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

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