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

NCT01432535 | Completed Phase 1 Results

• 2 other identifiers: P05655MK-4031-350
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Insufficiency

Outcome Measures

Primary Outcomes (7)

• 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.

  From hour 0 (pre-dose) to 288 hours post-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.

  From hour 0 (pre-dose) up to 288 hours post-dose

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Healthy Participants

ACTIVE COMPARATOR

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®)

Participants with Moderate Renal Impairment

EXPERIMENTAL

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®)

Participants with Severe Renal Impairment

EXPERIMENTAL

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®)

Interventions

PegIFN-2b (Sylatron®) DRUG

Single 4.5 μg/kg dose

Also known as: PegIntron®, Peginterferon alfa-2b, SCH 054031, MK-4031

Healthy Participants; Participants with Moderate Renal Impairment; Participants with Severe Renal Impairment

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Renal Insufficiency

Interventions

peginterferon alfa-2b

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2011
• First Posted: September 13, 2011
• Study Start: November 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 7, 2017
• Results First Posted: September 25, 2013

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share