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

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ClinicalTrials.gov Identifier: NCT01432535
Recruitment Status : Completed
First Posted : September 13, 2011
Results First Posted : September 25, 2013
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE September 9, 2011
First Posted Date  ICMJE September 13, 2011
Results First Submitted Date  ICMJE July 23, 2013
Results First Posted Date  ICMJE September 25, 2013
Last Update Posted Date April 7, 2017
Study Start Date  ICMJE November 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2013)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2011)
  • Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) [ Time Frame: From 0 hours (pre-dose) to 288 hours post-dose ]
  • Area under the concentration-time curve from time 0 to the time of the last measurable sample (AUClast) [ Time Frame: From 0 hours (pre-dose) to 288 hours post-dose ]
  • Maximum Observed Serum Concentration (Cmax) [ Time Frame: From 0 hours (pre-dose) to 288 hours post-dose ]
  • Time to Maximum Observed Serum Concentration (Tmax) [ Time Frame: From 0 hours (pre-dose) to 288 hours post-dose ]
Change History Complete list of historical versions of study NCT01432535 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655)
Official Title  ICMJE A Single Dose Study to Assess Pharmacokinetics of SCH 54031 in Patients With Renal Impairment (P05655)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Insufficiency
Intervention  ICMJE Drug: PegIFN-2b (Sylatron®)
Single 4.5 μg/kg dose
Other Names:
  • PegIntron®
  • Peginterferon alfa-2b
  • SCH 054031
  • MK-4031
Study Arms  ICMJE
  • 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.
    Intervention: Drug: PegIFN-2b (Sylatron®)
  • 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.
    Intervention: Drug: PegIFN-2b (Sylatron®)
  • 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.
    Intervention: Drug: PegIFN-2b (Sylatron®)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2012)
25
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2011)
24
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01432535
Other Study ID Numbers  ICMJE P05655
MK-4031-350 ( Other Identifier: Merck protocol number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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

Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP