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

Renal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432535
• Other study ID #: P05655
• Secondary ID: MK-4031-350
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2011
• Last updated: September 24, 2015
• Start date: November 2011
• Est. completion date: August 2012

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• PegIFN-2b (Sylatron®)
Single 4.5 µg/kg dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-8)	AUC0-8 is a measure of the mean concentration levels of drug in the plasma after the dose.	From hour 0 (pre-dose) to 288 hours post-dose	No
Primary	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.	From hour 0 (pre-dose) up to 288 hours post-dose	No
Primary	Maximum Observed Serum Concentration (Cmax)	Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.	From hour 0 (pre-dose) to 288 hours post-dose	No
Primary	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.	From hour 0 (pre-dose) up to 288 hours post-dose	No
Primary	Apparent Terminal Half-life (T1/2)	T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.	From hour 0 (pre-dose) up to 288 hours post-dose	No
Primary	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).	From hour 0 (pre-dose) up to 288 hours post-dose	No
Primary	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.	From hour 0 (pre-dose) up to 288 hours post-dose	No