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

Phase 1

Terminated

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: Boceprevir

• Registration Number: NCT01425190
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-26
• Study First Submitted QC: 2011-08-26
• Study First Posted: 2011-08-29
• Study Start: 2012-01-04
• Primary Completion: 2013-03-20
• Study Completion: 2013-03-20
• Results First Submitted: 2014-10-03
• Results First Submitted QC: 2014-10-03
• Results First Posted: 2014-10-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: Children 17 to ≥13 years	Boceprevir	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.
Cohort 2: Children <13 to ≥7 years	Boceprevir	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.
Cohort 3: Children <7 to ≥3 years	Boceprevir	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.

Primary Outcome Measures

Name	Time	Method
Area Under the Plasma Concentration Time Curve (AUC) From 0-Infinity of Single Dose Boceprevir	0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose	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	0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose	The maximum observed plasma concentration of boceprevir across sampling intervals was determined.
Time of Maximum Plasma Concentration (Tmax) of Single Dose Boceprevir	0 (pre-dose), 0.5, 1, 2, 2.5, 4.5, 5.5, 8, and 10 hours post dose	The time at which the maximum plasma boceprevir concentration was observed.
Final Dose of Boceprevir By Age Group	Day 1