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Pharmacokinetics of Peginterferon Alfa-2b in Participants With Moderate and Severe Renal Impairment (P05655 AM2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01432535
First received: September 9, 2011
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  Purpose

This study will compare the pharmacokinetics of a single dose of peginterferon alfa-2b in healthy participants to that in participants with moderate to severe impairment of kidney function.


Condition Intervention Phase
Renal Insufficiency
 Drug: Peginterferon alfa-2b
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Area under the concentration-time curve from time 0 to infinity (AUC0-∞) [ Time Frame: From 0 hours (pre-dose) to 288 hours post-dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Maximum observed serum concentration (Cmax) [ Time Frame: From 0 hours (pre-dose) to 288 hours post-dose ] [ Designated as safety issue: No ]
  • Time to maximum observed serum concentration (Tmax) [ Time Frame: From 0 hours (pre-dose) to 288 hours post-dose ] [ Designated as safety issue: No ]

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 Drug: Peginterferon alfa-2b
Single 4.5 mcg/kg dose
Other Name: PegIntron®
Experimental: Moderate renal impairment Drug: Peginterferon alfa-2b
Single 4.5 mcg/kg dose
Other Name: PegIntron®
Experimental: Severe renal impairment Drug: Peginterferon alfa-2b
Single 4.5 mcg/kg dose
Other Name: PegIntron®

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
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 OR 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® 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

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01432535     History of Changes
Other Study ID Numbers: P05655, MK-4031-350
Study First Received: September 9, 2011
Last Updated: September 18, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013