Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P07614)

This study has been terminated.
(The US FDA and the EU CHMP provided guidance indicating preference for intereferon-free regimens in pediatric studies of HCV infection.)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01425190
First received: August 26, 2011
Last updated: October 3, 2014
Last verified: October 2014
  Purpose

This is a study to determine the pharmacokinetics (PK) and weight-based dose of boceprevir following single oral dose administration in Chronic Hepatitis C Virus (HCV) pediatric participants.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Boceprevir
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: Assessment of the Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (Phase 1b); Protocol No. P07614

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose ] [ Designated as safety issue: No ]
    Plasma concentrations of boceprevir were determined at 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose.

  • Maximum Plasma Concentration (Cmax) of Single Dose Boceprevir [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose ] [ Designated as safety issue: No ]
    The maximum observed plasma concentration of boceprevir across sampling intervals was determined.

  • Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir [ Time Frame: 0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose ] [ Designated as safety issue: No ]
    The time at which the maximum plasma boceprevir concentration was observed.

  • Final Dose of Boceprevir By Age Group [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: January 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: Children 17 to ≥13 years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
Drug: Boceprevir
Single dose of boceprevir powder prior to breakfast in a dosing vehicle of chocolate pudding (i.e., a mousse or custard), apple sauce, Nutella, fruit pudding such as strawberry, cherry, or raspberry pudding, or yogurt or a similar semi-solid product into which the boceprevir powder can be evenly stirred
Other Name: SCH 503034
Experimental: Cohort 2: Children <13 to ≥7 years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
Drug: Boceprevir
Single dose of boceprevir powder prior to breakfast in a dosing vehicle of chocolate pudding (i.e., a mousse or custard), apple sauce, Nutella, fruit pudding such as strawberry, cherry, or raspberry pudding, or yogurt or a similar semi-solid product into which the boceprevir powder can be evenly stirred
Other Name: SCH 503034
Experimental: Cohort 3: Children <7 to ≥3 years
Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
Drug: Boceprevir
Single dose of boceprevir powder prior to breakfast in a dosing vehicle of chocolate pudding (i.e., a mousse or custard), apple sauce, Nutella, fruit pudding such as strawberry, cherry, or raspberry pudding, or yogurt or a similar semi-solid product into which the boceprevir powder can be evenly stirred
Other Name: SCH 503034

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documented chronic hepatitis C (CHC) genotype 1 infection
  • Treatment naïve or failed previous interferon/ribavirin therapy (≥12 uninterrupted weeks)
  • Weigh between 10 kg to 90 kg inclusive at screening and baseline (Day -1).
  • Body Mass Index (BMI) from the 5th to the 95th percentile for the participant's age and gender, inclusive, per tables from the Center for Disease Control and Prevention, USA
  • Use of acceptable methods of contraception for at least 3 months prior to baseline and continue on study

Exclusion Criteria:

  • Co-infection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive).
  • Treatment with ribavirin within 90 days, or any interferon-alfa within 30 days
  • Discontinued from interferon treatment due to adverse events
  • Currently receiving antiviral/immunomodulating therapy for hepatitis C
  • Prior treatment with an HCV protease inhibitor
  • Prior treatment with any known hepatotoxic agent (including herbal remedies)
  • Use of investigational drugs within 30 days of enrollment into study
  • Evidence of de-compensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
  • Substance abuse (including but not limited to alcohol abuse, illicit drugs,

inhalational drugs, marijuana use, etc) any time prior to entry into the study

  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug.
  • Pregnant or breastfeeding female
  • Meeting any of the laboratory exclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425190

Locations
United States, Massachusetts
Call for Information (Investigational Site 0002)
Boston, Massachusetts, United States, 02115-5724
United States, New York
Call for Information (Investigational Site 0001)
New York, New York, United States, 10029
United States, Pennsylvania
Call for Information (Investigational Site 0010)
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Call for Information (Investigational Site 0014)
Houston, Texas, United States, 77030
Germany
Merck Sharp & Dohme GmbH
Haar, Germany
Poland
MSD Polska Sp. Z o.o.
Warsaw, Poland
Spain
Merck Sharp and Dohme de Espana S.A.
Madrid, Spain
United Kingdom
Merck Sharp & Dohme Ltd.
Hoddesdon, United Kingdom
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01425190     History of Changes
Other Study ID Numbers: P07614, 2010-023498-20, MK-3034-063
Study First Received: August 26, 2011
Results First Received: October 3, 2014
Last Updated: October 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on October 19, 2014