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

• Status: Terminated
• Trial end date: 2013-03-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

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

• Meeting any of the laboratory exclusion criteria