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

NCT ID: NCT01425190

Last Updated: 2018-09-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-04
• Study Completion Date: 2013-03-20

Brief Summary

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.

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Boceprevir

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Boceprevir

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Boceprevir

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

SCH 503034

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

2010-023498-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MK-3034-063

Identifier Type: OTHER

Identifier Source: secondary_id

P07614

Identifier Type: -

Identifier Source: org_study_id