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

NCT01425190 | Terminated Phase 1 Results

• 3 other identifiers: P076142010-023498-20MK-3034-063
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Cohort 1: Children 17 to ≥13 years

EXPERIMENTAL

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

Cohort 2: Children <13 to ≥7 years

EXPERIMENTAL

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

Cohort 3: Children <7 to ≥3 years

EXPERIMENTAL

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

Interventions

Boceprevir 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

Also known as: SCH 503034

Cohort 1: Children 17 to ≥13 years; Cohort 2: Children <13 to ≥7 years; Cohort 3: Children <7 to ≥3 years

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: August 29, 2011
• Study Start: January 4, 2012
• Primary Completion: March 20, 2013
• Study Completion: March 20, 2013
• Last Updated: September 11, 2018
• Results First Posted: October 8, 2014

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share