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

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of the Pharmacokinetics of Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (Phase 1b); Protocol No. P07614

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: Boceprevir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Children 17 to ≥13 years<br>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<br>* 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<br>* Other names: SCH 503034;|
| Experimental: Cohort 2: Children <13 to ≥7 years<br>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<br>* 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<br>* Other names: SCH 503034;|
| Experimental: Cohort 3: Children <7 to ≥3 years<br>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<br>* 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<br>* Other names: SCH 503034;|

What is the study measuring?
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Primary Outcome Measures

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