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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 1

Conditions: Hepatitis C, Chronic

Treatments: Drug: Boceprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01425190

2010-023498-20 (EudraCT Number)

P07614

MK-3034-063 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

16 participants in 3 patient groups

Cohort 1: Children 17 to ≥13 years

Experimental group

Description:

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.

Treatment:

Drug: Boceprevir

Cohort 2: Children <13 to ≥7 years

Experimental group

Description:

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.

Treatment:

Drug: Boceprevir

Cohort 3: Children <7 to ≥3 years

Experimental group

Description:

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.

Treatment:

Drug: Boceprevir